Reusable applicators for transcutaneous analyte sensors, and associated methods

ABSTRACT

The present embodiments relate generally to systems and methods for measuring an analyte in a host. More particularly, the present embodiments provide sensor applicators and methods of use to insert the sensor into an individual&#39;s skin. Applicators are disclosed for inserting the sensor. Such applicators may be reusable applicators configured to implant multiple different sensors.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/566,491, filed Dec. 30, 2021, which claims the benefit of U.S.Provisional Application No. 63/132,703, filed Dec. 31, 2020, the entirecontents of each of which are incorporated by reference herein.

BACKGROUND OF THE INVENTION Field of the Invention

Systems and methods for measuring an analyte in an individual areprovided. More particularly, systems and methods are provided forapplying a transcutaneous analyte sensor to an individual.

Description of the Related Technology

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which can cause anarray of physiological derangements associated with the deterioration ofsmall blood vessels, for example, kidney failure, skin ulcers, orbleeding into the vitreous of the eye. A hypoglycemic reaction (lowblood sugar) can be induced by an inadvertent overdose of insulin, orafter a normal dose of insulin or glucose-lowering agent accompanied byextraordinary exercise or insufficient food intake.

Conventionally, a person with diabetes carries a self-monitoring bloodglucose (SMBG) monitor, which typically requires uncomfortable fingerpricking methods. Due to the lack of comfort and convenience, a personwith diabetes normally only measures his or her glucose levels two tofour times per day. Unfortunately, such time intervals are spread so farapart that the person with diabetes likely finds out too late of ahyperglycemic or hypoglycemic condition, sometimes incurring dangerousside effects. Glucose levels may be alternatively monitored continuouslyby a measurement system including an on-skin sensor assembly. The sensorassembly may have a wireless transmitter which transmits measurementdata to a receiver which can process and display information based onthe measurements.

The process of applying the sensor to the person is important for such asystem to be effective and user friendly. The application process shouldresult in the on-skin sensor assembly being attached to the person in astate where it is capable of sensing the analyte (e.g., glucose) levelinformation, communicating the sensed data to the transmitter, andtransmitting the analyte level information to the receiver.

Existing systems tend to utilize types of applicators for the sensorthat were single-use and intended to be disposed after such use. Theapplicators may insert the sensor into the skin of the individual, andthen be discarded. Another applicator may then be used to insert anothersensor into the skin of the individual at a desired time.

Such systems may result in multiple single-use applicators produced anddistributed for use on the individual. Production of multiple of suchsingle-use applicators may be costly and may be considered to bewasteful. Reusable applicators may desirably reduce the costs and wasteassociated with applying sensors into the skin of the individual.

This Background is provided to introduce a brief context for the Summaryand Detailed Description that follow. This Background is not intended tobe an aid in determining the scope of the claimed subject matter nor beviewed as limiting the claimed subject matter to implementations thatsolve any or all of the disadvantages or problems presented above.

SUMMARY

The present systems and methods relate to systems and methods formeasuring an analyte in a host, and for applying a transcutaneousanalyte measurement system to a host. The various embodiments of thepresent systems and methods for applying the analyte measurement systemhave several features, no single one of which is solely responsible fortheir desirable attributes. Without limiting the scope of the presentembodiments as expressed by the claims that follow, their more prominentfeatures now will be discussed briefly. After considering thisdiscussion, and particularly after reading the section entitled“Detailed Description,” one will understand how the features of thepresent embodiments provide the advantages described herein.

In a first aspect, a system for inserting a transcutaneous analytesensor into an individual's skin may be provided, the system includingan applicator housing configured to be gripped to apply thetranscutaneous analyte sensor into the individual's skin. The system mayinclude an actuator coupled to the applicator housing and configured toinsert a needle into the individual's skin, wherein the needle isconfigured to guide the transcutaneous analyte sensor into theindividual's skin. The system may include a releasable couplerconfigured retain the needle at least partially within the applicatorhousing following insertion of the transcutaneous analyte sensor intothe individual's skin, and release the needle from within the applicatorhousing.

Implementations of the embodiments may include one or more of thefollowing. The actuator may include a control device configured to beoperated by the individual; and a driver configured to drive the needleinto the individual's skin to guide the transcutaneous analyte sensorinto the individual's skin. The actuator may further comprise a carriageconfigured to slide relative to the applicator housing and configured tobe slid by the driver. The driver may include a spring. A releaseactuator may be configured to release the needle from the releasablecoupler. The release actuator may include a control device configured tobe operated by the individual to cause the needle to release from thereleasable coupler. The control device may be configured to be operatedin a first operation to activate the actuator configured to insert theneedle into the individual's skin, and is configured to be operated in asecond operation following the first operation to activate the releaseactuator. The first operation may include pressing the control device,and the second operation includes pressing the control device. Thecontrol device may be configured to protrude from the applicator housingto a different distance for the first operation than for the secondoperation. The release actuator may further comprise a pressing surfaceconfigured to apply a force to the releasable coupler to cause theneedle to release from the releasable coupler. The releasable couplermay be configured to couple to a needle hub of the needle. A retractionactuator may be for retracting the needle from the individual's skinfollowing insertion of the transcutaneous analyte sensor into theindividual's skin. The retraction actuator may be configured toautomatically operate upon the needle guiding the transcutaneous analytesensor into the individual's skin. The retraction actuator may beconfigured to activate based on a force of contact with the individual'sskin at a deployment site of the transcutaneous analyte sensor. A firstcarriage may be configured to displace relative to a second carriagebased on contact with the individual's skin to operate the releaseactuator. A spring may bias the first carriage away from the secondcarriage. The retraction actuator may include a driver configured todrive the needle out of the individual's skin; and a carriage configuredto slide relative to the applicator housing and configured to be slid bythe driver of the retraction actuator. The releasable coupler may becoupled to the carriage of the retraction actuator. The carriage of theretraction actuator may be a first carriage and the driver of theretraction actuator is a first driver and the releasable coupler is afirst releasable coupler, and the actuator configured to insert theneedle into the individual's skin includes a second carriage configuredto slide relative to the applicator housing and configured to be slid bya second driver, and further comprising a second releasable coupler forcoupling the first carriage to the second carriage. The secondreleasable coupler may be configured to release the first carriage fromthe second carriage to allow the first driver to move the first carriagein a direction away from the second carriage. The second releasablecoupler may be configured to automatically release upon contact with acoupler release. The retraction actuator may be configured to positionthe needle into a needle cover. The retraction actuator may beconfigured to rotate the needle into the needle cover. The releasablecoupler configured to retain the needle is configured to release theneedle positioned within the needle cover from within the applicatorhousing. The releasable coupler may be configured to rotate to hook ontoor release from a needle hub of the needle. The applicator housing mayinclude a top portion, a side portion, and a bottom portion including anopening for the transcutaneous analyte sensor to be deployed from to beguided into the individual's skin. The side portion may include anopening for receiving a cartridge retaining the transcutaneous analytesensor. The system may further comprise a cartridge configured to beinserted into the applicator housing and to retain the transcutaneousanalyte sensor. The cartridge may retain the needle and retains awearable housing for the transcutaneous analyte sensor. The cartridgemay retain a patch for the wearable housing that has a liner, and thecartridge is coupled to the patch such that withdrawal of the cartridgefrom the wearable housing removes the liner from the patch. Thecartridge may be configured to be inserted into the applicator housingto provide energy to the actuator. The cartridge may be configured to beremoved from the applicator housing prior to the needle being insertedinto the individual's skin. The cartridge may include a needle couplerconfigured to engage a used needle that is retained within theapplicator housing and retain the used needle when the cartridge iswithdrawn from the applicator housing. The cartridge may include anupper surface and a lower surface facing opposite the upper surface, anda retainer is positioned on the upper surface for retaining thetranscutaneous analyte sensor, and the needle coupler is positioned onthe lower surface. The cartridge may include an upper surface and alower surface facing opposite the upper surface, and a retainer ispositioned on the upper surface for retaining the transcutaneous analytesensor, and the needle coupler is positioned on the upper surface. Thecartridge may be configured to remain in a receiver of the applicatorhousing during the needle being inserted into the individual's skin toguide the transcutaneous analyte sensor into the individual's skin. Thecartridge may include a retraction actuator for retracting the needlefrom the individual's skin following insertion of the transcutaneousanalyte sensor into the individual's skin. The cartridge may include abottom surface with an opening for the transcutaneous analyte sensor tobe deployed from and a patch for the transcutaneous analyte sensorcoupled to the bottom surface and covering the opening. Thetranscutaneous analyte sensor may be configured to slide within thecartridge relative to the patch. The applicator housing may include areceiver for receiving the cartridge, and the cartridge includes a keyedportion configured to align the cartridge with the receiver in a singlerotational orientation. The actuator may be a reloadable actuatorconfigured to insert multiple different needles into the individual'sskin. The applicator housing may include an opening at a bottom surfaceof the applicator housing for the transcutaneous analyte sensor to bedeployed from, and the actuator includes a needle carriage configured toretain the needle after insertion into the individual's skin and rotatethe needle about an axis that is vertical with respect to the opening.The system may include a pull tab configured to be pulled to release theneedle from the releasable coupler. The pull tab may be configured tocouple to a needle hub of the needle. The actuator may include a controldevice configured to be operated by the individual, and the applicatorhousing includes a roughened outer surface indicating a position of thecontrol device.

In a second aspect, a system for inserting a transcutaneous analytesensor into an individual's skin may be provided. The system may includean applicator housing configured to be gripped to apply thetranscutaneous analyte sensor into the individual's skin and including areceiver configured to receive a cartridge retaining the transcutaneousanalyte sensor. The system may include an actuator configured to inserta needle into the individual's skin to guide the transcutaneous analytesensor into the individual's skin, the actuator configured such thatinsertion of the cartridge into the receiver provides energy to theactuator.

Implementations of the embodiments may include one or more of thefollowing. The actuator may include a driver configured to drive theneedle into the individual's skin to guide the transcutaneous analytesensor into the individual's skin, the actuator configured such thatinsertion of the cartridge into the receiver provides energy to thedriver. The driver may include a spring configured to drive the needleinto the individual's skin to guide the transcutaneous analyte sensorinto the individual's skin, and the actuator is configured such thatinsertion of the cartridge into the receiver compresses the spring. Theactuator may be an insertion actuator, and further comprising aretraction actuator configured to retract the needle from theindividual's skin, the retraction actuator configured to activate basedon a force of contact with the individual's skin at a deployment site ofthe transcutaneous analyte sensor. A first carriage may be configured todisplace relative to a second carriage based on contact with theindividual's skin to operate the release actuator. A spring may bias thefirst carriage away from the second carriage. The actuator may be aninsertion actuator, and further comprising a retraction actuatorconfigured to retract the needle from the individual's skin, and theretraction actuator is configured such that insertion of the cartridgeinto the receiver provides energy to the retraction actuator. Theretraction actuator may include a driver configured to retract theneedle from the individual's skin, the retraction actuator beingconfigured such that insertion of the cartridge into the receiverprovides energy to the driver of the retraction actuator. The driver ofthe retraction actuator may include a spring configured to retract theneedle from the individual's skin, and the actuator is configured suchthat insertion of the cartridge into the receiver compresses the springof the retraction actuator. The retraction actuator may be configured torotate the needle into a needle cover. The insertion actuator mayinclude a carriage configured to be moved by a spring that is configuredto drive the needle into the individual's skin to guide thetranscutaneous analyte sensor into the individual's skin, and theretraction actuator includes a carriage configured to be moved by thespring of the retraction actuator in a direction away from the carriageof the insertion actuator. The system may include a releasable couplerfor coupling the carriage of the insertion actuator to the carriage ofthe retraction actuator to resist a force of the spring of theretraction actuator. The system may include a releasable coupler coupledto the carriage of the retraction actuator and configured to retain theneedle at least partially within the applicator housing followinginsertion of the transcutaneous analyte sensor into the individual'sskin, and release the needle from within the applicator housing. Thereleasable coupler may be configured to rotate to hook onto or releasefrom a needle hub of the needle. The system may include a pull tabconfigured to be pulled to release the needle from the releasablecoupler. The pull tab may be configured to couple to a needle hub of theneedle. The system may include a release actuator configured to releasethe needle from the releasable coupler. The system may include a controldevice configured to be operated in a first operation to activate theactuator configured to insert the needle into the individual's skin, andis configured to be operated in a second operation following the firstoperation to activate the release actuator. The first operation mayinclude pressing the control device, and the second operation includespressing the control device. The control device may be configured toprotrude from the applicator housing to a different distance for thefirst operation than for the second operation. The applicator housingmay include a top portion, a side portion, and a bottom portionincluding an opening for the transcutaneous analyte sensor to bedeployed from to be guided into the individual's skin. The receiver maybe configured to receive the cartridge through the opening. The sideportion may include an opening, and the receiver is configured toreceive the cartridge through the opening of the side portion. Theactuator may be configured such that a force applied by the cartridge tothe actuator provides energy to the actuator. The system may include acartridge, and wherein the cartridge includes a pressing surface forpressing against the actuator for providing energy to the actuator. Thecartridge may include a bottom surface with an opening for thetranscutaneous analyte sensor to be deployed from and a patch for thetranscutaneous analyte sensor coupled to the bottom surface and coveringthe opening. The cartridge may be configured to allow the transcutaneousanalyte sensor to slide within the cartridge relative to the patch. Thecartridge may retain a patch for a wearable housing for thetranscutaneous analyte sensor, the patch having a liner, and thecartridge is coupled to the patch such that withdrawal of the cartridgefrom the wearable housing removes the liner from the patch. Thecartridge may include a retraction actuator for retracting the needlefrom the individual's skin following insertion of the transcutaneousanalyte sensor into the individual's skin. The cartridge may include aneedle coupler configured to engage a used needle that is retainedwithin the applicator housing and retain the used needle when theapplicator housing is withdrawn from the applicator housing. Thecartridge may include an upper surface and a lower surface facingopposite the upper surface, and a retainer is positioned on the uppersurface for retaining the transcutaneous analyte sensor, and the needlecoupler is positioned on the lower surface. The cartridge may include anupper surface and a lower surface facing opposite the upper surface, anda retainer is positioned on the upper surface for retaining thetranscutaneous analyte sensor, and the needle coupler is positioned onthe upper surface. The applicator housing may include an opening at abottom surface of the applicator housing for the transcutaneous analytesensor to be deployed from, and the actuator includes a needle carriageconfigured to retain the needle after insertion into the individual'sskin and rotate the needle about an axis that is vertical with respectto the opening. The applicator housing may include a receiver forreceiving the cartridge, and the cartridge includes a keyed portionconfigured to align the cartridge with the receiver in a singlerotational orientation. The actuator may include a control deviceconfigured to be operated by the individual, and the applicator housingincludes a roughened outer surface indicating a position of the controldevice.

In a third aspect, a system for inserting a transcutaneous analytesensor into an individual's skin may be provided, the system includingan applicator housing configured to be gripped to apply thetranscutaneous analyte sensor into the individual's skin. The system mayinclude an insertion actuator coupled to the applicator housing andconfigured to insert a needle into the individual's skin to guide thetranscutaneous analyte sensor into the individual's skin. The system mayinclude a releasable coupler configured to retain the needle at leastpartially within the applicator housing. The system may include arelease actuator configured to release the needle from the releasablecoupler.

Implementations of the embodiments may include one or more of thefollowing. The release actuator may be configured to eject the needlefrom the applicator housing. The release actuator may include a pressingsurface configured to apply force to the needle to eject the needle fromthe applicator housing. The release actuator may include a controldevice configured to be operated by the individual to cause the needleto release from the releasable coupler. The control device may include abutton. The control device may be configured to activate the insertionactuator. The control device may be configured to be operated in a firstoperation to activate the insertion actuator, and is configured to beoperated in a second operation following the first operation to activatethe release actuator. The first operation may include pressing thecontrol device, and the second operation includes pressing the controldevice. The control device may be configured to protrude from theapplicator housing to a different distance for the first operation thanfor the second operation. The applicator housing may include a topportion, a side portion, and a bottom portion including an opening forthe transcutaneous analyte sensor to be deployed from to be insertedinto the individual's skin, the release actuator configured to releasethe needle from the releasable coupler to allow the needle to be passedthrough the opening. The applicator housing may include a receiverconfigured to receive a cartridge retaining the transcutaneous analytesensor, and the release actuator is configured to be operated to allowthe cartridge to be removed from the receiver. The release actuator maybe configured to unlock the cartridge from the applicator housing. Thesystem may include the cartridge, and wherein the cartridge includes aretraction actuator for retracting the needle from the individual's skinfollowing insertion of the transcutaneous analyte sensor into theindividual's skin. The system may include the cartridge, wherein thecartridge includes a bottom surface with an opening for thetranscutaneous analyte sensor to be deployed from and a patch for thetranscutaneous analyte sensor coupled to the bottom surface and coveringthe opening. The cartridge may be configured to allow the transcutaneousanalyte sensor to slide within the cartridge relative to the patch. Thecartridge may be configured to allow the needle to slide within thecartridge relative to the patch. The patch may be configured to bedeployed to the individual's skin from the bottom surface of thecartridge. The system may include the cartridge, wherein the cartridgeincludes a keyed portion configured to align the cartridge with thereceiver in a single rotational orientation. The release actuator may beconfigured to release a needle cover from the applicator housing. Thesystem may include a cartridge retaining the transcutaneous analytesensor, the needle, and a needle cover, and wherein the needle isconfigured to be moved relative to the needle cover to be positionedinto the needle cover. The release actuator may be configured to releasethe needle covered by the needle cover from within the applicatorhousing. The needle and the needle cover may form a unit configured tobe ejected from within the applicator housing by the release actuator.The releasable coupler may be configured to rotate to hook onto orrelease from a needle hub of the needle. The system may include aretraction actuator configured to retract the needle from theindividual's skin, the retraction actuator configured to activate basedon a force of contact with the individual's skin at a deployment site ofthe transcutaneous analyte sensor. The insertion actuator may include acontrol device configured to be operated by the individual, and theapplicator housing includes a roughened outer surface indicating aposition of the control device.

In a fourth aspect, a system for inserting a transcutaneous analytesensor into an individual's skin may be provided, the system may includean applicator housing configured to be gripped to apply thetranscutaneous analyte sensor into the individual's skin, the applicatorhousing including a top portion, a side portion, and a bottom portion,the side portion including an opening for the transcutaneous analytesensor to be inserted into, and the bottom portion including an openingfor the transcutaneous analyte sensor to be deployed from. The systemmay include an actuator coupled to the applicator housing and configuredto insert a needle into the individual's skin from the opening of thebottom portion to guide the transcutaneous analyte sensor into theindividual's skin.

Implementations of the embodiments may include one or more of thefollowing. The opening of the bottom portion may be configured for theneedle and the transcutaneous analyte sensor to pass through to guidethe transcutaneous analyte sensor into the individual's skin. Theapplicator housing may include a receiver configured to receive thetranscutaneous analyte sensor through the opening of the side portion.The receiver may include a cavity. The receiver may be configured toreceive a cartridge retaining the transcutaneous analyte sensor throughthe opening of the side portion. The actuator may be configured suchthat insertion of the cartridge into the receiver provides energy to theactuator. The actuator may be configured such that insertion of thecartridge into the receiver compresses a spring of the actuator, thespring configured to drive the needle into the individual's skin toguide the transcutaneous analyte sensor into the individual's skin. Thesystem may include a cocking device for providing energy to theactuator. The cocking device may include a lever for compressing aspring of the actuator, the spring configured to drive the needle intothe individual's skin to guide the transcutaneous analyte sensor intothe individual's skin. The system may include a cartridge retaining thetranscutaneous analyte sensor and the needle. The cartridge may includean inner cartridge body and an outer cartridge body. The outer cartridgebody may be configured to be separated from the inner cartridge bodyprior to the actuator inserting the needle into the individual's skin.The system may include a releasable coupler configured to retain theneedle at least partially within the applicator housing followinginsertion of the transcutaneous analyte sensor into the individual'sskin, and release the needle from within the applicator housing. Thecartridge may be configured to be withdrawn from the receiver throughthe opening of the side portion to release the needle from thereleasable coupler. The system may include a retraction actuator forretracting the needle from the individual's skin following insertion ofthe transcutaneous analyte sensor into the individual's skin.

In a fifth aspect, a system for inserting a transcutaneous analytesensor into an individual's skin may be provided, the system includingan applicator housing configured to be gripped to apply thetranscutaneous analyte sensor into the individual's skin. The system mayinclude an actuator coupled to the applicator housing and configured toinsert a needle into the individual's skin to guide the transcutaneousanalyte sensor into the individual's skin. The system may include acocking device configured to be manually operated to cock the actuatorfor insertion of the needle into the individual's skin.

Implementations of the embodiments may include one or more of thefollowing. The cocking device may include a lever configured to bemanually pressed. The cocking device may be configured to be manuallyoperated to provide energy to the actuator. The actuator may include adriver configured to drive the needle into the individual's skin toguide the transcutaneous analyte sensor into the individual's skin, andthe cocking device is configured to provide energy to the driver. Thedriver may include a spring configured to drive the needle into theindividual's skin to guide the transcutaneous analyte sensor into theindividual's skin, and the cocking device is configured to compress thespring. The actuator may include a carriage configured to slide relativeto the applicator housing and configured to be slid by the spring, andthe cocking device is configured to move the carriage to compress thespring. The cocking device may be coupled to the carriage. Theapplicator housing may include a top portion, a side portion, and abottom portion including an opening for the transcutaneous analytesensor to be deployed from to be inserted into the individual's skin.The side portion may include an opening for receiving a cartridgeretaining the transcutaneous analyte sensor. The cocking device may beconfigured to move at least a portion of the cartridge upon beingmanually operated. The actuator may include a control device configuredto be manually operated to activate the actuator. The cocking device maybe configured to be in an initial uncocked state and manually moved to acocked state in which cocking device cocks the actuator, and the controldevice is configured such that operation of the control device returnsthe cocking device to an uncocked state. The cocking device may protrudefrom the applicator housing. A releasable coupler may be configured toretain the needle at least partially within the applicator housingfollowing insertion of the transcutaneous analyte sensor into theindividual's skin, and release the needle from within the applicatorhousing. The system may include retraction actuator for retracting theneedle from the individual's skin following insertion of thetranscutaneous analyte sensor into the individual's skin.

In a sixth aspect, a system for inserting a transcutaneous analytesensor into an individual's skin may be provided. The system may includean applicator housing including a receiver configured to receive acartridge retaining the transcutaneous analyte sensor and a needle forguiding the transcutaneous analyte sensor into skin of an individual,the receiver configured to release the cartridge from the applicatorhousing. The system may include an actuator coupled to the applicatorhousing and configured to insert the needle into the individual's skinwith the cartridge positioned within the receiver to guide thetranscutaneous analyte sensor into the individual's skin.

Implementations of the embodiments may include one or more of thefollowing. The receiver may comprise a cavity within the applicatorhousing. The system may include a releasable coupler for retaining theneedle at least partially within the applicator housing. The releasablecoupler may be configured to release the cartridge from the applicatorhousing to release the needle from the applicator housing. The systemmay include a cartridge, and wherein the cartridge defines a cavity forreceiving the transcutaneous analyte sensor. The cartridge may include akeyed portion configured to align the cartridge with the receiver in asingle rotational orientation. The cartridge may include a retractionactuator for retracting the needle from the individual's skin followinginsertion of the transcutaneous analyte sensor into the individual'sskin. The retraction actuator may be configured to activate based on aforce of contact with the individual's skin at a deployment site of thetranscutaneous analyte sensor. A first carriage may be configured todisplace relative to a second carriage based on contact with theindividual's skin to operate the release actuator. A spring may bias thefirst carriage away from the second carriage. The cartridge may includea bottom surface with an opening for the transcutaneous analyte sensorto be deployed from and a patch for the transcutaneous analyte sensorcoupled to the bottom surface and covering the opening. The cartridgemay be configured to allow the transcutaneous analyte sensor to slidewithin the cartridge relative to the patch. The cartridge may beconfigured to allow the needle to slide within the cartridge relative tothe patch. The patch may be configured to be deployed to theindividual's skin from the bottom surface of the cartridge. The systemmay include the cartridge, and wherein the cartridge includes a wallextending around the transcutaneous analyte sensor. The wall may beconfigured to extend around the needle. The wall may include an innersurface configured to face inward towards the transcutaneous analytesensor, and includes an outer surface facing opposite the inner surface.The outer surface may comprise a mating surface for the receiver. Themating surface may be contoured to a shape of an inner surface of thereceiver. The system may include a protrusion on the outer surfaceconfigured to align the cartridge with the receiver. The system mayinclude the cartridge, and wherein the cartridge is configured to retainthe needle after the cartridge has been separated from the receiver andthe needle has been inserted into the individual's skin. The system mayinclude the cartridge, and the transcutaneous analyte sensor and theneedle coupled to the cartridge. The system may include a needle covercoupled to the cartridge. The cartridge may include a removable covercovering the transcutaneous analyte sensor and the needle within thecartridge. The actuator may include a control device configured to beoperated by the individual, and the applicator housing includes aroughened outer surface indicating a position of the control device.

In a seventh aspect, a cartridge for coupling to an applicator housingof a transcutaneous analyte sensor applicator may be provided. Thecartridge may include a transcutaneous analyte sensor. The cartridge mayinclude a needle configured to guide the transcutaneous analyte sensorinto skin of an individual. The cartridge may include a needle coverconfigured to cover at least a portion of the needle following theneedle guiding the transcutaneous analyte sensor into the skin of theindividual. The cartridge may include a body configured to be coupled tothe applicator housing and including a retainer retaining thetranscutaneous analyte sensor and including a wall extending around atleast a portion of the transcutaneous analyte sensor.

Implementations of the embodiments may include one or more of thefollowing. The body may include an upper opening. The cartridge mayinclude a removable cover covering the upper opening. The removablecover may form a hermetic seal of the upper opening. The removable covermay comprise a flap. The removable cover may comprise a body having aheight and width and covering the needle cover. The cartridge mayinclude a wearable housing for the transcutaneous analyte sensor coupledto the transcutaneous analyte sensor, and wherein the needle cover iscoupled to the wearable housing. The wearable housing may be configuredto couple to an electronics unit. The needle cover may be configured tobe separable from the wearable housing. The needle cover may comprise asheath configured to extend over at least the portion of the needle. Theneedle cover may be configured to rotate relative to the needle toextend over at least the portion of the needle. The wall may extendaround at least a portion of the needle cover. The wall may include aninner surface configured to face inward towards the transcutaneousanalyte sensor, and includes an outer surface facing opposite the innersurface and configured to be positioned within the applicator housing.The outer surface may have an asymmetrical contour. The cartridge mayinclude a protrusion on the outer surface configured to align the bodywith the applicator housing.

In an eighth aspect, a system for inserting a transcutaneous analytesensor into an individual's skin may be provided. The system may includean applicator housing configured to be gripped to apply thetranscutaneous analyte sensor into the individual's skin. The system mayinclude an actuator coupled to the applicator housing and configured toinsert a needle into the individual's skin to guide the transcutaneousanalyte sensor into the individual's skin. The system may include areceiver configured to retain the transcutaneous analyte sensor withinthe applicator housing. The system may include a mounting baseconfigured to retain an electronics unit for the transcutaneous analytesensor and configured to apply the electronics unit to a coupler for thetranscutaneous analyte sensor when the transcutaneous analyte sensor isretained by the receiver, to couple the electronics unit to thetranscutaneous analyte sensor.

Implementations of the embodiments may include one or more of thefollowing. The receiver may include a cavity configured to receive themounting base. The receiver may be configured to retain thetranscutaneous analyte sensor within the cavity. The applicator housingmay include an opening for the mounting base to be passed through toenter the cavity. The opening may be positioned at a bottom portion ofthe applicator housing, and the receiver is positioned at an upperportion of the cavity. The receiver may include an inner surfaceextending between a lower portion of the receiver and an upper portionof the receiver and surrounding the cavity. The mounting base mayinclude an upper surface configured to retain the electronics unit, alower surface, and one or more side surfaces extending between the uppersurface and the lower surface. The one or more side surfaces may beshaped to mate with the inner surface of the receiver. The system mayinclude a protrusion on the one or more side surfaces configured toalign the mounting base with the receiver. The receiver may bepositioned on a carriage of an insertion actuator configured to insertthe needle and the transcutaneous analyte sensor into the individual'sskin. The receiver may form at least a portion of a cartridge configuredfor insertion into the applicator housing. The mounting base may beconfigured to be inserted into the cartridge to apply the electronicsunit to the coupler for the transcutaneous analyte sensor. The mountingbase may be configured to be removed from the cartridge prior to theneedle guiding the transcutaneous analyte sensor into the individual'sskin. The mounting base may be configured to be inserted into theapplicator housing to apply the electronics unit to the coupler for thetranscutaneous analyte sensor. The mounting base may be configured to beremoved from the applicator housing prior to the needle guiding thetranscutaneous analyte sensor into the individual's skin.

In a ninth aspect, a cartridge for coupling to an applicator housing ofa transcutaneous analyte sensor applicator. The cartridge may include abody configured to be coupled to the applicator housing; a retainerconfigured to retain a transcutaneous analyte sensor to the body; areceiver configured to receive an unused needle that is coupled to thetranscutaneous analyte sensor; and a needle coupler configured to engagea used needle that is retained within the applicator housing and retainthe used needle when the body is withdrawn from the applicator housing.

Implementations of the embodiments may include one or more of thefollowing. The body may include an upper surface and a lower surfacefacing opposite the upper surface, and the retainer is positioned on theupper surface and the needle coupler is positioned on the lower surface.The body may be configured to be inserted into a receiver of theapplicator housing with the upper surface facing towards the applicatorhousing and alternatively with the lower surface facing towards theapplicator housing. The body may include an upper surface and a lowersurface facing opposite the upper surface, and the retainer ispositioned on the upper surface and the needle coupler is positioned onthe upper surface. The transcutaneous analyte sensor may be coupled tothe retainer and the unused needle positioned within the receiver andcoupled to the transcutaneous analyte sensor, and wherein the bodyincludes a wall extending around at least a portion of thetranscutaneous analyte sensor.

In a tenth aspect, a system for inserting a transcutaneous analytesensor into an individual's skin, the system comprising: an applicatorhousing configured to be gripped to apply the transcutaneous analytesensor into the individual's skin and including an opening at a bottomsurface of the applicator housing for the transcutaneous analyte sensorto be deployed from; a driver for inserting a needle into theindividual's skin to guide the transcutaneous analyte sensor into theindividual's skin; and a needle carriage configured to retain the needleafter insertion into the individual's skin and rotate the needle aboutan axis that is vertical with respect to the opening.

Implementations of the embodiments may include one or more of thefollowing. The driver may be configured to drive the needle carriagetowards the individual's skin to insert the needle into the individual'sskin. A gear may be for rotating the needle carriage about the axis. Acartridge may include a needle coupler for engaging the needle towithdraw the needle from the needle carriage. The needle carriage may beconfigured to rotate the needle to align with the needle coupler.

In an eleventh aspect, a cartridge for coupling to an applicator housingof a transcutaneous analyte sensor applicator, the cartridge comprising:a transcutaneous analyte sensor; a body configured to be coupled to theapplicator housing and including a bottom surface with an opening forthe transcutaneous analyte sensor to be deployed from; a needleconfigured to guide the transcutaneous analyte sensor into skin of anindividual; and a patch for the transcutaneous analyte sensor coupled tothe bottom surface and covering the opening.

Implementations of the embodiments may include one or more of thefollowing. A wearable housing for the transcutaneous analyte sensor,wherein the wearable housing is spaced from the patch. The wearablehousing may be configured to slide relative to the patch. The needle maybe configured to slide relative to the patch to guide the transcutaneousanalyte sensor into the skin of the individual. A retraction actuatormay be for retracting the needle from the skin of the individual.

In a twelfth aspect, a cartridge for coupling to an applicator housingof a transcutaneous analyte sensor applicator, the cartridge comprising:a transcutaneous analyte sensor; a needle configured to guide thetranscutaneous analyte sensor into skin of an individual; and a firstbody retaining the transcutaneous analyte sensor and the needle andconfigured to be coupled to the applicator housing, the first bodyincluding a bottom cavity configured to receive a second body having asame shape as the first body to stack the first body upon the secondbody.

Implementations of the embodiments may include one or more of thefollowing. A cover covering an upper opening of the first body. Thefirst body may include an upper cavity retaining the transcutaneousanalyte sensor and the needle. The first body may have a bottom surfacethat is wider than an upper surface of the first body. The first bodymay have a trapezoidal shape.

In a thirteenth aspect, a method of applying a transcutaneous analytesensor into an individual's skin may be provided. The method may includeutilizing an actuator coupled to an applicator housing to insert aneedle into the individual's skin to guide the transcutaneous analytesensor into the individual's skin, the needle positioned at leastpartially within the applicator housing. The method may includewithdrawing the applicator housing from the individual's skin with theneedle positioned at least partially within the applicator housing afterthe needle has guided the transcutaneous analyte sensor into theindividual's skin. The method may include separating the needle from theapplicator housing.

Implementations of the embodiments may include one or more of thefollowing. The actuator may comprise a reusable actuator. The method mayinclude discarding the needle after the needle has been separated fromthe applicator housing. The needle may be positioned in a needle coverafter the needle has guided the transcutaneous analyte sensor into theindividual's skin, and the method further comprises separating theneedle cover from the applicator housing. The method may includeejecting the needle and the needle cover from the applicator housingwith the needle positioned in the needle cover. The method may includediscarding the needle and the needle cover as a unit. The method mayinclude operating a retraction actuator to cover the needle with theneedle cover. The method may include operating the retraction actuatorto rotate the needle into the needle cover. The method may includeoperating a control device to release the needle from the applicatorhousing. The control device may be configured to be operated in a firstoperation to activate the actuator to insert the needle into theindividual's skin, and is configured to be operated in a secondoperation following the first operation to activate a release actuatorto release the needle from the applicator, and the control deviceprotrudes from the applicator housing to a different distance for thefirst operation than for the second operation. The method may includereleasing the needle from a releasable coupler that retains the needleat least partially within the applicator housing. The releasable couplermay retain the needle at least partially within the applicator housingwhile the applicator housing is withdrawn from the individual's skin.The releasable coupler may rotate to hook onto or release from a needlehub of the needle. The method may include pulling a pull tab to releasethe needle from the releasable coupler. The method may include providingenergy to the actuator by inserting the transcutaneous analyte sensorinto the applicator housing. The method may include providing energy tothe actuator by inserting a cartridge retaining the transcutaneousanalyte sensor into the applicator housing. The cartridge may retain apatch for a wearable housing that has a liner, and the method furthercomprises withdrawing the cartridge from the wearable housing to removethe liner from the patch. The cartridge may include a needle couplerconfigured to engage a used needle that is retained within theapplicator housing and retain the used needle when the applicatorhousing is withdrawn from the applicator housing. The cartridge mayinclude an upper surface and a lower surface facing opposite the uppersurface, and a retainer is positioned on the upper surface for retainingthe transcutaneous analyte sensor, and the needle coupler is positionedon the lower surface. The cartridge may include an upper surface and alower surface facing opposite the upper surface, and a retainer ispositioned on the upper surface for retaining the transcutaneous analytesensor, and the needle coupler is positioned on the upper surface.Providing energy to the actuator may include compressing a spring of theactuator. The actuator may be an insertion actuator, and inserting thetranscutaneous analyte sensor into the applicator housing compresses aspring of a retraction actuator for retracting the needle from theindividual's skin. The method may include utilizing the actuator toinsert multiple different transcutaneous analyte sensors into theindividual's skin. The method may include deploying the transcutaneousanalyte sensor from a cartridge that remains in a receiver of theapplicator housing during the needle being inserted into theindividual's skin to guide the transcutaneous analyte sensor into theindividual's skin. The cartridge may include a retraction actuator forretracting the needle from the individual's skin following insertion ofthe transcutaneous analyte sensor into the individual's skin. Thecartridge may include a bottom surface with an opening for thetranscutaneous analyte sensor to be deployed from and a patch for thetranscutaneous analyte sensor coupled to the bottom surface and coveringthe opening. The applicator housing may include an opening at a bottomsurface of the applicator housing for the transcutaneous analyte sensorto be deployed from, and the actuator includes a needle carriageconfigured to retain the needle after insertion into the individual'sskin and rotate the needle about an axis that is vertical with respectto the opening. A retraction actuator for retracting the needle from theindividual's skin may activate based on a force of contact with theindividual's skin at a deployment site of the transcutaneous analytesensor. The actuator may include a control device configured to beoperated by the individual, and the applicator housing includes aroughened outer surface indicating a position of the control device. Themethod may include deploying the transcutaneous analyte sensor from acartridge that includes a keyed portion configured to align thecartridge with a receiver of the applicator housing in a singlerotational orientation.

In a fourteenth aspect, a method of applying a transcutaneous analytesensor into an individual's skin may be provided. The method may includeinserting a transcutaneous analyte sensor into an opening in a sideportion of an applicator housing, the applicator housing including a topportion and a bottom portion including an opening. The method mayinclude inserting the transcutaneous analyte sensor into theindividual's skin from the opening in the bottom portion of theapplicator housing.

Implementations of the embodiments may include one or more of thefollowing. The method may include inserting a needle into theindividual's skin from the opening in the bottom portion of theapplicator housing to guide the transcutaneous analyte sensor into theindividual's skin. The method may include inserting a cartridgeretaining the transcutaneous analyte sensor into the opening in the sideportion of an applicator housing to insert the transcutaneous analytesensor into the opening in the side portion of the applicator housing.Inserting the cartridge into the opening in the side portion of theapplicator housing may include inserting the cartridge in a receiver ofthe applicator housing, and the method may further comprise leaving thecartridge in the receiver of the applicator housing while thetranscutaneous analyte sensor is inserted into the individual's skin.Inserting the cartridge into the opening in the side portion of anapplicator housing may provide energy to an actuator for inserting thetranscutaneous analyte sensor into the individual's skin.

In a fifteenth aspect, a method of applying a transcutaneous analytesensor into an individual's skin may be provided. The method may includemanually cocking an insertion actuator of a reusable applicator for thetranscutaneous analyte sensor. The method may include utilizing theinsertion actuator to insert a needle into the individual's skin toguide the transcutaneous analyte sensor into the individual's skin.

Implementations of the embodiments may include one or more of thefollowing. Manually cocking the insertion actuator may include manuallyoperating a cocking device extending from a housing of the reusableapplicator. The cocking device may include a lever configured to bemanually pressed. Manually cocking the insertion actuator may includecompressing a spring of the insertion actuator. Manually cocking theinsertion actuator may include compressing a spring of a retractionactuator for retracting the needle from the individual's skin.

In a sixteenth aspect, a method of applying a transcutaneous analytesensor into an individual's skin may be provided. The method may includecoupling a cartridge retaining a transcutaneous analyte sensor and aneedle to an applicator housing including an actuator. The method mayinclude utilizing the actuator to insert the transcutaneous analytesensor and the needle into the individual's skin with the cartridgeremaining coupled to the applicator housing. The method may includeseparating the cartridge from the applicator housing after the needlehas guided the transcutaneous analyte sensor into the individual's skin.

Implementations of the embodiments may include one or more of thefollowing. The method may include coupling the cartridge to theapplicator housing by inserting the cartridge into a receiver of theapplicator housing. The cartridge may include a keyed portion configuredto align the cartridge with the receiver in a single rotationalorientation. The method may include inserting the cartridge into anopening of the applicator housing that the transcutaneous analyte sensoris inserted into the individual's skin from. The method may includeseparating the needle from the applicator housing by separating thecartridge from the applicator housing. The method may include operatinga release actuator to release the needle from the applicator housing.The method may include operating the release actuator to release thecartridge from the applicator housing. The cartridge may include aretraction actuator for retracting the needle from the individual's skinfollowing insertion of the transcutaneous analyte sensor into theindividual's skin. The retraction actuator may be configured to activatebased on a force of contact with the individual's skin at a deploymentsite of the transcutaneous analyte sensor. A first carriage may beconfigured to displace relative to a second carriage based on contactwith the individual's skin to operate the release actuator. A spring maybias the first carriage away from the second carriage. The cartridge mayinclude a bottom surface with an opening for the transcutaneous analytesensor to be deployed from and a patch for the transcutaneous analytesensor coupled to the bottom surface and covering the opening. Thetranscutaneous analyte sensor may be configured to slide within thecartridge relative to the patch. The method may comprise applying thepatch from the bottom surface of the cartridge to the individual's skin.The actuator may include a control device configured to be operated bythe individual, and the applicator housing includes a roughened outersurface indicating a position of the control device.

In a seventeenth aspect, a method of applying a transcutaneous analytesensor into an individual's skin may be provided. The method may includecoupling a cartridge to an applicator housing, the cartridge including:the transcutaneous analyte sensor, a needle configured to guide thetranscutaneous analyte sensor into the skin of an individual, a needlecover configured to cover at least a portion of the needle after theneedle guides the transcutaneous analyte sensor into the skin of theindividual, and a body retaining the transcutaneous analyte sensor andhaving a wall extending around at least a portion of the transcutaneousanalyte sensor. The method may include utilizing an actuator coupled tothe applicator housing to insert the needle into the individual's skinto guide the transcutaneous analyte sensor into the individual's skin.The method may include covering the needle with the needle cover afterthe needle has guided the transcutaneous analyte sensor into theindividual's skin.

Implementations of the embodiments may include one or more of thefollowing. The method may include releasing the needle covered with theneedle cover from the applicator housing. The method may includediscarding the needle covered with the needle cover. The method mayinclude coupling the cartridge to the applicator housing by insertingthe cartridge into a receiver of the applicator housing. The method mayinclude leaving the cartridge within the receiver while the actuator isutilized to insert the needle into the individual's skin to guide thetranscutaneous analyte sensor into the individual's skin. The cartridgemay include a keyed portion configured to align the cartridge with thereceiver in a single rotational orientation. The actuator may include acontrol device configured to be operated by the individual, and theapplicator housing includes a roughened outer surface indicating aposition of the control device. The actuator may include a controldevice that is configured to be operated in a first operation toactivate the actuator, and is configured to be operated in a secondoperation following the first operation to activate a release actuatorconfigured to release the needle from a releasable coupler. The firstoperation may include pressing the control device, and the secondoperation includes pressing the control device. The control device mayprotrude from the applicator housing to a different distance for thefirst operation than for the second operation.

In an eighteenth aspect, a method of applying a transcutaneous analytesensor into an individual's skin may be provided. The method may includeproviding an electronics unit for the transcutaneous analyte sensor on amounting base. The method may include coupling the electronics unit tothe transcutaneous analyte sensor. The method may include separating themounting base from the electronics unit. The method may includeinserting the transcutaneous analyte sensor into the individual's skinwhile the transcutaneous analyte sensor is coupled to the electronicsunit.

Implementations of the embodiments may include one or more of thefollowing. The electronics unit may include a communication device forthe transcutaneous analyte sensor. The method may include inserting themounting base into a receiver retaining the transcutaneous analytesensor. The receiver may be positioned on a carriage of an insertionactuator configured to insert a needle and the transcutaneous analytesensor into the individual's skin. The method may include coupling theelectronics unit to a wearable housing to couple the electronics unit tothe transcutaneous analyte sensor.

In a nineteenth aspect, a method comprising: coupling a cartridge to anapplicator housing, the cartridge including: a transcutaneous analytesensor, an unused needle configured to guide the transcutaneous analytesensor into skin of an individual, and a needle coupler configured toengage a used needle that is retained within the applicator housing andretain the used needle when the cartridge is withdrawn from theapplicator housing; withdrawing the cartridge from the applicatorhousing; and retaining the used needle to the cartridge with the needlecoupler when the cartridge is withdrawn from the applicator housing.

Implementations of the embodiments may include one or more of thefollowing. The cartridge may include an upper surface and a lowersurface facing opposite the upper surface, and the transcutaneousanalyte sensor is positioned on the upper surface and the needle coupleris positioned on the lower surface. The method may include inserting thecartridge into a receiver of the applicator housing with the lowersurface facing the applicator housing; rotating the cartridge so thatthe upper surface faces the applicator housing; and inserting thecartridge into the receiver of the applicator housing with the uppersurface facing the applicator housing. The method may include rotating acarriage within the applicator housing to position the used needle foralignment with the needle coupler. The method may include inserting thecartridge into a receiver of the applicator housing to engage the needlecoupler with the used needle.

In a twentieth aspect, a cartridge for coupling to an applicator housingof a transcutaneous analyte sensor applicator, the cartridge comprising:a transcutaneous analyte sensor; a needle configured to guide thetranscutaneous analyte sensor into skin of an individual; and acartridge body configured to be coupled to the applicator housing andconfigured to retain the transcutaneous analyte sensor and the needle,and including a removable body configured to retain a used needle and tobe removable from the cartridge body to separate the used needle fromthe cartridge body.

Implementations of the embodiments may include one or more of thefollowing. The removable body may have a smaller volume than a portionof the cartridge body remaining after the removable body is removed fromthe cartridge body. A pull body may be coupled to the removable body andconfigured to be pulled to remove the removable body from the cartridgebody. The removable body may comprise an insert positioned within thecartridge body. The cartridge body may be configured to be split apartto release the removable body from the cartridge body.

In a twenty-first aspect, a method comprising: coupling a cartridge toan applicator housing, the cartridge including: a transcutaneous analytesensor, a needle configured to guide the transcutaneous analyte sensorinto skin of an individual, and a cartridge body configured to becoupled to the applicator housing and configured to retain thetranscutaneous analyte sensor and the needle, and including a removablebody configured to retain a used needle and to be removable from thecartridge body to separate the used needle from the cartridge body.

Implementations of the embodiments may include one or more of thefollowing. The removable body may have a smaller volume than a portionof the cartridge body remaining after the removable body is removed fromthe cartridge body. A pull body may be coupled to the removable body andconfigured to be pulled to remove the removable body from the cartridgebody. The removable body may comprise an insert positioned within thecartridge body. The cartridge body may be configured to be split apartto release the removable body from the cartridge body.

In further aspects and embodiments, the above methods and features ofthe various aspects are formulated in terms of a system as in variousaspects, having an applicator configured to carry out the methodfeatures. Any of the features of an embodiment of any of the aspects,including but not limited to any embodiments of any of the first throughtwenty-first aspects referred to above, is applicable to all otheraspects and embodiments identified herein, including but not limited toany embodiments of any of the first through twenty-first aspectsreferred to above. Moreover, any of the features of an embodiment of thevarious aspects, including but not limited to any embodiments of any ofthe first through twenty-first aspects referred to above, isindependently combinable, partly or wholly with other embodimentsdescribed herein in any way, e.g., one, two, or three or moreembodiments may be combinable in whole or in part. Further, any of thefeatures of an embodiment of the various aspects, including but notlimited to any embodiments of any of the first through twenty-firstaspects referred to above, may be made optional to other aspects orembodiments. Any aspect or embodiment of a method can be performed by asystem or apparatus of another aspect or embodiment, and any aspect orembodiment of a system or apparatus can be configured to perform amethod of another aspect or embodiment, including but not limited to anyembodiments of any of the first through twenty-first aspects referred toabove.

This Summary is provided to introduce a selection of concepts in asimplified form. The concepts are further described in the DetailedDescription section. Elements or steps other than those described inthis Summary are possible, and no element or step is necessarilyrequired. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended foruse as an aid in determining the scope of the claimed subject matter.The claimed subject matter is not limited to implementations that solveany or all disadvantages noted in any part of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages are described belowwith reference to the drawings, which are intended to illustrate, butnot to limit, the disclosure. In the drawings, like reference charactersdenote corresponding features consistently throughout similarembodiments.

FIG. 1 is a schematic view of an on-skin sensor assembly positioned onan individual and communicating with other devices.

FIG. 2 illustrates a perspective view of a system.

FIG. 3 illustrates a perspective view of components of an on-skin sensorassembly.

FIG. 4 illustrates an exploded view of components of an on-skin sensorassembly.

FIG. 5 illustrates an exploded view of components of a cartridge.

FIG. 6 illustrates a perspective view of a cartridge.

FIG. 7 illustrates an exploded perspective view of the applicator shownin FIG. 2.

FIG. 8 illustrates a perspective assembly view of a carriage of theapplicator shown in FIG. 2.

FIG. 9 illustrates a bottom perspective view of a carriage of theapplicator shown in FIG. 2.

FIG. 10 illustrates a perspective assembly view of the carriage shown inFIG. 8 and the carriage shown in FIG. 9.

FIG. 11 illustrates a perspective assembly view of the carriage shown inFIG. 8 coupled with the carriage shown in FIG. 9.

FIG. 12 illustrates a perspective assembly view of the carriages shownin FIGS. 8 and 9 inserted into a housing of an applicator shown in FIG.2.

FIG. 13 illustrates a perspective assembly view the housing of theapplicator shown in FIG. 2.

FIG. 14 illustrates a top perspective assembly view of the housing ofthe applicator shown in FIG. 2.

FIG. 15 illustrates a perspective view of a control device.

FIG. 16 illustrates a perspective assembly view of the control device ofFIG. 15 inserted into the housing of the applicator shown in FIG. 2.

FIG. 17 illustrates a top perspective assembly view of the housing ofthe applicator shown in FIG. 2.

FIG. 18 illustrates a bottom perspective view of a release actuator.

FIG. 19 illustrates a perspective assembly view of a release actuator ofFIG. 18 inserted into the housing of the applicator shown in FIG. 2.

FIG. 20 illustrates a perspective assembly view of the housing of theapplicator shown in FIG. 2.

FIG. 21 illustrates a cross sectional view of the applicator shown inFIG. 2 along line I-I, with a cross section of a cartridge taken alongthe same line I-I.

FIG. 22 illustrates a cross sectional view of the applicator shown inFIG. 2 along line I-I, with a cross section of a cartridge taken alongthe same line I-I.

FIG. 23 illustrates a cross sectional view of the applicator shown inFIG. 2 along line II-II, which is orthogonal to the view of line I-I.

FIG. 24 illustrates a cross sectional view of the applicator shown inFIG. 2 along line I-I.

FIG. 25 illustrates a perspective cross sectional view of the applicatorshown in FIG. 2 along line which is orthogonal to the view of line I-I.

FIG. 26 illustrates a perspective cross sectional view of the applicatorshown in FIG. 2 along line I-I.

FIG. 27 illustrates a perspective cross sectional view of the applicatorshown in FIG. 2 along line II-II.

FIG. 28 illustrates a perspective cross sectional view of the applicatorshown in FIG. 2 along line I-I.

FIG. 29 illustrates a perspective view of an on-skin sensor assemblypositioned on an individual's skin.

FIG. 30 illustrates an exploded view of components of a cartridge.

FIG. 31 illustrates a perspective view of a needle and needle cover.

FIG. 32 illustrates a perspective cross sectional view of the needle andneedle cover shown in FIG. 31 along line IV-IV.

FIG. 33 illustrates a top perspective view of the cartridge shown inFIG. 30.

FIG. 34 illustrates a cross sectional view of the cartridge shown inFIG. 33 along line V-V.

FIG. 35 illustrates a cross sectional view of an applicator along a lineII-II as shown in FIG. 2.

FIG. 36 illustrates a cross sectional view of an applicator along a lineI-I as shown in FIG. 2.

FIG. 37 illustrates a cross sectional view of an applicator along a lineI-I as shown in FIG. 2.

FIG. 38 illustrates a perspective view of an applicator.

FIG. 39 illustrates a perspective view of an applicator and a cartridge.

FIG. 40 illustrates a perspective view of a cartridge.

FIG. 41 illustrates a perspective view of a needle and a needle cover.

FIG. 42 illustrates a perspective view of the needle cover of FIG. 41extending over the needle of FIG. 41.

FIG. 43 illustrates a cross sectional view of an applicator and acartridge along a mid-line of the applicator and cartridge.

FIG. 44 illustrates a perspective view of a carriage of the applicatorshown in FIG. 43.

FIG. 45 illustrates a bottom perspective view of the carriage shown inFIG. 44.

FIG. 46 illustrates a perspective view of a carriage of the applicatorshown in FIG. 43.

FIG. 47 illustrates a perspective view of a control device of theapplicator shown in FIG. 43.

FIG. 48 illustrates a bottom perspective view of a release actuator ofthe applicator shown in FIG. 43.

FIG. 49 illustrates a perspective assembly view of the carriages shownin FIGS. 44 and 46 and the control device shown in FIG. 47.

FIG. 50 illustrates a cross sectional view of an applicator and acartridge along the mid-line of the applicator and cartridge shown inFIG. 43.

FIG. 51 illustrates a cross sectional view of an applicator and acartridge along the mid-line of the applicator and cartridge shown inFIG. 43.

FIG. 52 illustrates a perspective view of a cartridge.

FIG. 53 illustrates a cross sectional view of an applicator and thecartridge shown in FIG. 52.

FIG. 54 illustrates a close up perspective cross sectional view of aused needle engaging a needle coupler.

FIG. 55 illustrates a perspective view of a cartridge.

FIG. 56 illustrates a cross sectional perspective view of an applicatorand the cartridge shown in FIG. 55.

FIG. 57 illustrates a close up perspective cross sectional view of aneedle carriage of the applicator shown in FIG. 56.

FIG. 58 illustrates a close up perspective cross sectional view of aneedle carriage of the applicator shown in FIG. 56.

FIG. 59 illustrates a cross sectional view of the applicator shown inFIG. 56.

FIG. 60 illustrates an exploded perspective view of a cartridge.

FIG. 61 illustrates a cross-sectional perspective view of an assembledcartridge along line VI-VI shown in FIG. 60.

FIG. 62 illustrates a perspective exploded view of an applicator.

FIG. 63 illustrates a perspective view of a carriage of the applicator.

FIG. 64 illustrates a bottom perspective view of the carriage of theapplicator shown in FIG. 62.

FIG. 65 illustrates a perspective view of the lever arm of theapplicator shown in FIG. 62.

FIG. 66 illustrates a rear perspective view of a control device of theapplicator shown in FIG. 62.

FIG. 67 illustrates a cross-sectional perspective view of the applicatorof FIG. 62 along line VII-VII.

FIG. 68 illustrates a close up perspective view of a portion of theapplicator shown in FIG. 62.

FIG. 69 illustrates a close up perspective view of a portion of theapplicator shown in FIG. 62.

FIG. 70 illustrates a cross-sectional perspective view of the applicatorof FIG. 62 along line VII-VII.

FIG. 71 illustrates a cross-sectional perspective view of the applicatorof FIG. 62 along line VII-VII.

FIG. 72 illustrates a cross-sectional perspective view of the applicatorof FIG. 62 along line VII-VII.

FIG. 73 illustrates a perspective view of a needle.

FIG. 74 illustrates a cross sectional view of a cartridge along a midline of the cartridge.

FIG. 75 illustrates a perspective exploded view of an applicator.

FIG. 76 illustrates a perspective view of a carriage of the applicatorshown in FIG. 75.

FIG. 77 illustrates a bottom perspective view of a carriage of theapplicator shown in FIG. 75.

FIG. 78 illustrates a perspective view of a carriage of the applicatorshown in FIG. 75.

FIG. 79 illustrates a bottom perspective view of a carriage of theapplicator shown in FIG. 75.

FIG. 80 illustrates a rear perspective view of a control device of theapplicator shown in FIG. 75.

FIG. 81 illustrates a cross sectional view of the applicator along lineVIII-VIII of FIG. 75.

FIG. 82 illustrates a cross sectional view of the applicator along lineIX-IX of FIG. 75, which is orthogonal to line VIII-VIII.

FIG. 83 illustrates a perspective view of coupled carriages of theapplicator shown in FIG. 75.

FIG. 84 illustrates a cross sectional view of the applicator along lineX-X of FIG. 75, which is orthogonal to line VIII-VIII.

FIG. 85 illustrates a close up cross sectional view of a releasablecoupler for the applicator in a view that is orthogonal to lineVIII-VIII.

FIG. 86 illustrates a close up cross sectional view of the applicatoralong line VIII-VIII of FIG. 75.

FIG. 87 illustrates a close up cross sectional view of the applicator ina view that is orthogonal to line VIII-VIII of FIG. 75.

FIG. 88 illustrates a close up cross sectional view of the applicator inthe view of FIG. 87.

FIG. 89 illustrates a perspective view of a needle extending from acarriage of the applicator shown in FIG. 75.

FIG. 90 illustrates a cross sectional view of the applicator along lineVIII-VIII of FIG. 75.

FIG. 91 illustrates a cross sectional perspective view of the applicatoralong line VIII-VIII of FIG. 75.

FIG. 92 illustrates a cross sectional view of the applicator along lineVIII-VIII of FIG. 75.

FIG. 93 illustrates a perspective view of a cartridge.

FIG. 94 illustrates a cross sectional view of the cartridge of FIG. 93.

FIG. 95 illustrates a perspective view of a carriage.

FIG. 96 illustrates a perspective view of a carriage.

FIG. 97 illustrates a perspective view of a carriage.

FIG. 98 illustrates a perspective view of an interior housing for anapplicator.

FIG. 99 illustrates a three quarters cross section perspective view ofan applicator and the cartridge of FIG. 93.

FIG. 100 illustrates a three quarters cross section perspective view ofthe applicator and the cartridge of FIG. 99.

FIG. 101 illustrates a three quarters cross section perspective view ofthe applicator and the cartridge of FIG. 99.

FIG. 102 illustrates a three quarters cross section perspective view ofthe applicator and the cartridge of FIG. 99.

FIG. 103 illustrates a three quarters cross section perspective view ofthe applicator and the cartridge of FIG. 99.

FIG. 104 illustrates a three quarters cross section perspective view ofthe applicator and the cartridge of FIG. 99.

FIG. 105 illustrates a three quarters cross section perspective view ofthe applicator and the cartridge of FIG. 99.

FIG. 106 illustrates a three quarters cross section perspective view ofthe applicator and the cartridge of FIG. 99.

FIG. 107 illustrates a perspective view of a cartridge.

FIG. 108 illustrates a perspective view of a pull tab extending from anapplicator.

FIG. 109 illustrates a liner and cartridge being pulled from a patch.

FIG. 110 illustrates a perspective view of a needle and needle coverpositioned within a cartridge shown in three quarters cross sectionview.

FIG. 111 illustrates a perspective view of a carriage shown in partialcross sectional view.

FIG. 112 illustrates a perspective view of a carriage shown in partialcross sectional view.

FIG. 113 illustrates a three quarters cross section perspective view ofthe cartridge of FIG. 110 and an applicator.

FIG. 114 illustrates a three quarters cross section perspective view ofthe cartridge of FIG. 110 and an applicator of FIG. 113.

FIG. 115 illustrates a three quarters cross section perspective view ofthe applicator of FIG. 113.

FIG. 116 illustrates a three quarters cross section perspective view ofthe applicator of FIG. 113.

FIG. 117 illustrates a three quarters cross section perspective view ofthe applicator of FIG. 113.

FIG. 118 illustrates a three quarters cross section perspective view ofthe applicator of FIG. 113.

FIG. 119 illustrates a three quarters cross section perspective view ofthe applicator of FIG. 113.

FIG. 120 illustrates an exploded perspective view of a cartridge.

FIG. 121 illustrates a cross sectional view of the assembled cartridgealong line XI-XI of FIG. 120.

FIG. 122 illustrates a top perspective view of the assembled cartridgeof FIG. 120.

FIG. 123 illustrates an exploded view of an applicator.

FIG. 124 illustrates a perspective view of a carriage of the applicatorshown in FIG. 123.

FIG. 125 illustrates a perspective view of a carriage of an applicatorshown in FIG. 123.

FIG. 126 illustrates a rear perspective view of a control device of anapplicator shown in FIG. 123.

FIG. 127 illustrates a cross sectional view of the applicator along lineXII-XII shown in FIG. 123.

FIG. 128 illustrates a cross-sectional view of the applicator along lineXIII-XIII shown in FIG. 123, which is orthogonal to line XII-XII.

FIG. 129 illustrates a perspective cross-sectional view of theapplicator along line XIII-XIII shown in FIG. 123, which is orthogonalto line XII-XII.

FIG. 130 illustrates a cross sectional view of the applicator along lineXII-XII shown in FIG. 123.

FIG. 131 illustrates a cross sectional view of the applicator along lineXII-XII shown in FIG. 123.

FIG. 132 illustrates a cross-sectional view of the applicator along lineXIII-XIII shown in FIG. 123, which is orthogonal to line XII-XII.

FIG. 133 illustrates a cross sectional view of the applicator along lineXII-XII shown in FIG. 123.

FIG. 134 illustrates a perspective cross sectional view of theapplicator along line XII-XII shown in FIG. 123.

FIG. 135 illustrates a perspective cross sectional view of theapplicator along line XII-XII shown in FIG. 123.

FIG. 136 illustrates a top down cross sectional view of the applicatorshown in FIG. 123, along a mid line of the control device shown in FIG.123.

FIG. 137 illustrates a cross sectional view of a cartridge.

FIG. 138 illustrates an exploded perspective view of an applicator.

FIG. 139 illustrates a cross sectional view of the applicator along lineXV-XV shown in FIG. 138.

FIG. 140 illustrates a cross sectional view of the applicator along lineXVI-XVI shown in FIG. 138.

FIG. 141 illustrates a cross sectional view of the applicator along lineXV-XV shown in FIG. 138.

FIG. 142 illustrates a close up perspective cross sectional view of theapplicator along line XV-XV shown in FIG. 138.

FIG. 143 illustrates a cross sectional view of the applicator along lineXVI-XVI shown in FIG. 138.

FIG. 144 illustrates a cross sectional view of the applicator along lineXVI-XVI shown in FIG. 138.

FIG. 145 illustrates a cross sectional view of the applicator along lineXV-XV shown in FIG. 138.

FIG. 146 illustrates an exploded view of a cartridge.

FIG. 147 illustrates a three quarters cross section perspective view ofthe cartridge of FIG. 146 and an applicator.

FIG. 148 illustrates a three quarters cross section perspective view ofthe cartridge of FIG. 146 and the applicator of FIG. 147.

FIG. 149 illustrates a three quarters cross section perspective view ofthe cartridge of FIG. 146 and the applicator of FIG. 147.

FIG. 150 illustrates a three quarters cross section perspective view ofthe cartridge of FIG. 146 and the applicator of FIG. 147.

FIG. 151 illustrates a three quarters cross section perspective view ofthe cartridge of FIG. 146 and the applicator of FIG. 147.

FIG. 152 illustrates a top perspective view of a patch.

FIG. 153 illustrates a bottom perspective view of the patch of FIG. 152.

FIG. 154 illustrates a bottom perspective view of a cartridge.

FIG. 155 illustrates a perspective view of a component of the cartridgeshown in FIG. 154.

FIG. 156 illustrates a cross sectional view of a cartridge shown in FIG.154.

FIG. 157 illustrates a perspective view of a component of a cartridge.

FIG. 158 illustrates a cross sectional view of a cartridge including thecomponent shown in FIG. 157.

FIG. 159 illustrates a perspective assembly view of an applicator and amounting base.

FIG. 160 illustrates a cross sectional view an applicator housing, acartridge, and a mounting base.

FIG. 161 illustrates a perspective view of an applicator and acartridge.

FIG. 162 illustrates a perspective top view of a cartridge shown in FIG.161.

FIG. 163 illustrates a cross sectional view of an applicator and acartridge along line XVII-XVII in FIG. 161.

FIG. 164 illustrates a cross sectional view of an applicator and acartridge along line XVII-XVII in FIG. 161.

FIG. 165 illustrates a cross sectional view of an applicator and acartridge along line XVII-XVII in FIG. 161.

FIG. 166 illustrates a cross sectional view of an applicator and acartridge along line XVII-XVII in FIG. 161.

FIG. 167 illustrates a perspective view of an applicator and acartridge.

FIG. 168 illustrates a perspective view of the cartridge shown in FIG.167.

FIG. 169 illustrates an assembly view of the cartridge shown in FIG.167.

FIG. 170 illustrates a front perspective view of the applicator shown inFIG. 167.

FIG. 171 illustrates a rear perspective view of the applicator shown inFIG. 167.

FIG. 172 illustrates a cross sectional view along line XVIII-XVIII ofthe applicator and the cartridge shown in FIG. 167.

FIG. 173 illustrates a cross sectional view along line XVIII-XVIII ofthe applicator and the cartridge shown in FIG. 167.

FIG. 174 illustrates an exploded view of an on-skin sensor assembly.

FIG. 175 illustrates an exploded view of an on-skin sensor assembly.

FIG. 176 illustrates an exploded view of an on-skin sensor assembly.

FIG. 177 illustrates an exploded view of an on-skin sensor assembly.

FIG. 178 illustrates an exploded view of an on-skin sensor assembly.

FIG. 179 illustrates an exploded view of an on-skin sensor assembly.

FIG. 180 illustrates an exploded view of an on-skin sensor assembly.

FIG. 181 illustrates an exploded view of an on-skin sensor assembly.

FIG. 182 illustrates a schematic view of an on-skin sensor assembly.

FIG. 183 illustrates a schematic view of an on-skin sensor assembly.

FIG. 184 illustrates a top view of an on-skin sensor assembly.

FIG. 185 illustrates a schematic view of an on-skin sensor assembly.

FIG. 186 illustrates a schematic view of a coupler for an on-skin sensorassembly.

FIG. 187 illustrates a schematic view of a coupler for an on-skin sensorassembly.

FIG. 188 illustrates a perspective view of a cartridge.

FIG. 189 illustrates a cross sectional schematic of the cartridge shownin FIG. 188.

FIG. 190 illustrates a perspective view of cartridges stacked upon eachother.

FIG. 191 illustrates a container system.

FIG. 192 illustrates a perspective view of a cartridge within acontainer having a seal.

FIG. 193 illustrates a perspective view of a cartridge having a seal.

FIG. 194 illustrates a perspective view of a cartridge having a seal.

FIG. 195 illustrates a perspective view of the cartridge of FIG. 194having the seal broken.

FIG. 196 illustrates a perspective view of an applicator having a bottomcover.

FIG. 197 illustrates a side view of an applicator and a cartridge.

FIG. 198 illustrates an exploded view of components of a cartridge.

FIG. 199 illustrates a perspective view of the cartridge shown in FIG.198.

FIG. 200 illustrates a perspective view of components of a cartridge.

FIG. 201 illustrates a perspective view of components of a cartridge.

FIG. 202 illustrates a perspective view of components of a cartridge.

FIG. 203 illustrates an exploded perspective view of an applicator.

FIG. 204 illustrates a three quarters cross section perspective view ofthe applicator shown in FIG. 203 and a cartridge.

FIG. 205 illustrates a three quarters cross section perspective view ofthe applicator shown in FIG. 203 and a cartridge.

FIG. 206 illustrates a three quarters cross section perspective view ofthe applicator shown in FIG. 203 and a cartridge.

FIG. 207 illustrates a three quarters cross section perspective view ofthe applicator shown in FIG. 203 and a cartridge.

FIG. 208 illustrates a three quarters cross section perspective view ofthe applicator shown in FIG. 203.

FIG. 209 illustrates a three quarters cross section perspective view ofthe applicator shown in FIG. 203.

FIG. 210 illustrates a cross sectional view of the applicator shown inFIG. 203 along a mid line.

FIG. 211 illustrates a three quarters cross section perspective view ofthe applicator shown in FIG. 203.

FIG. 212 illustrates a cross sectional view of the applicator shown inFIG. 203 along a mid line.

FIG. 213 illustrates a perspective view of an applicator housing beingwithdrawn from a deployment site.

FIG. 214 illustrates a perspective view of a pull tab being pulled froman applicator housing.

FIG. 215 illustrates an exploded perspective view of an applicator.

FIG. 216 illustrates a cross sectional view of the applicator shown inFIG. 215 along a mid line.

FIG. 217 illustrates a cross sectional view of the applicator shown inFIG. 215 along a transverse cross sectional plane.

FIG. 218 illustrates a cross sectional view of the applicator shown inFIG. 215 along a mid line.

FIG. 219 illustrates a cross sectional view of the applicator shown inFIG. 215 along a transverse cross sectional plane.

FIG. 220 illustrates a cross sectional view of the applicator shown inFIG. 215 along a vertical plane.

FIG. 221 illustrates a cross sectional view of the applicator shown inFIG. 215 along a mid line.

FIG. 222 illustrates a cross sectional view of the applicator shown inFIG. 215 along a transverse cross sectional plane.

FIG. 223 illustrates a cross sectional view of the applicator shown inFIG. 215 along a mid line.

FIG. 224 illustrates an exploded perspective view of a cartridge.

FIG. 225 illustrates a perspective view of components of a cartridge.

FIG. 226 illustrates a cross sectional view of a cartridge shown in FIG.224.

FIG. 227 illustrates a close up view of a portion of the cartridge shownin FIG. 224.

FIG. 228 illustrates a cross sectional view of a cartridge shown in FIG.224.

FIG. 229 illustrates a cross sectional view of a cartridge shown in FIG.224.

FIG. 230 illustrates a close up view of a portion of the cartridge shownin FIG. 224.

FIG. 231 illustrates a close up view of a portion of the cartridge shownin FIG. 224.

FIG. 232 illustrates a cross sectional view of a cartridge shown in FIG.224.

FIG. 233 illustrates an exploded perspective view of a cartridge.

FIG. 234 illustrates a perspective view of components of a cartridge.

FIG. 235 illustrates a cross sectional view of a cartridge shown in FIG.233.

FIG. 236 illustrates a cross sectional view of a cartridge shown in FIG.233.

FIG. 237 illustrates a close up view of a portion of the cartridge shownin FIG. 233.

FIG. 238 illustrates a close up view of a portion of a cartridge.

FIG. 239 illustrates a close up view of a portion of a cartridge.

FIG. 240 illustrates a perspective view of components of a cartridge.

FIG. 241 illustrates a cross sectional view of a portion of anapplicator including a releasable coupler.

FIG. 242 illustrates a cross sectional view of the portion of theapplicator shown in FIG. 241.

FIG. 243 illustrates a cross sectional view of the portion of theapplicator shown in FIG. 241.

FIG. 244 illustrates a cross sectional view of the portion of theapplicator shown in FIG. 241.

FIG. 245 illustrates a perspective view of a cartridge.

FIG. 246A illustrates a perspective view of a removable body of acartridge.

FIG. 246B illustrates a perspective view of the cartridge including theremovable body shown in FIG. 246A.

FIG. 247A illustrates a perspective view of a removable body of acartridge.

FIG. 247B illustrates a perspective view of a cartridge including theremovable body shown in FIG. 247A.

FIG. 248A illustrates a perspective view of a removable body of acartridge.

FIG. 248B illustrates a perspective view of a cartridge including theremovable body shown in FIG. 248A.

DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS

The following description and examples illustrate some exampleembodiments of the disclosure in detail. Those of skill in the art willrecognize that there are numerous variations and modifications of thedisclosure that are encompassed by its scope. Accordingly, thedescription of a certain example embodiment should not be deemed tolimit the scope of the present disclosure.

FIG. 1 illustrates a schematic view of a transcutaneous analytemeasurement system 10. The transcutaneous analyte measurement system 10may comprise a continuous analyte measurement system for continuouslymeasuring an analyte of an individual. The transcutaneous analytemeasurement system 10 may include a transcutaneous analyte sensorsystem, which may be in the form of a wearable or on-skin sensorassembly 12, which is shown fastened to the skin of an individual via adisposable housing (not shown). The on-skin sensor assembly 12 may beattached to the individual and be configured to communicate with one ormore other example devices 16, 18, 20, 22 of the transcutaneous analytemeasurement system 10. The on-skin sensor assembly 12 may include atranscutaneous analyte sensor 24 and an electronics unit 26 (which maybe referred to interchangeably as “sensor electronics,” “communicationsdevice,” or “transmitter”) for wirelessly transmitting analyteinformation to a receiver. During use, a sensing portion of thetranscutaneous analyte sensor 24 is under the individual's skin and acontact portion of the transcutaneous analyte sensor 24 may beelectrically connected to the electronics unit 26. The electronics unit26 may be engaged with a housing that may be attached to an adhesivepatch fastened to the skin of the individual.

The on-skin sensor assembly 12 may be attached to the individual withuse of an applicator that may be adapted to provide convenient andsecure application. Such an applicator may also be used for insertingthe transcutaneous analyte sensor 24 through the individual's skin. Oncethe transcutaneous analyte sensor 24 has been inserted, the applicatormay detach from the on-skin sensor assembly 12 and may be removed fromthe transcutaneous analyte sensor 24.

In general, the transcutaneous analyte measurement system 10 may includeany sensor configuration that provides an output signal indicative of aconcentration of an analyte. The output signal including (e.g., sensordata, such as a raw data stream, filtered data, smoothed data, and/orotherwise transformed sensor data) is sent to a receiver which may bee.g., a smart phone, smart watch, dedicated device and the like (markedas example devices 16, 18, 20, 22 in FIG. 1). In one embodiment, thetranscutaneous analyte measurement system 10 includes a transcutaneousglucose sensor, such as is described in US Patent Publication No.US-2011-0027127-A1, the contents of which are hereby incorporated byreference in its entirety. In some embodiments, the transcutaneousanalyte measurement system 10 includes a continuous glucose sensor andcomprises a transcutaneous sensor such as described in U.S. Pat. No.6,565,509 to Say et al., for example. In another embodiment, thetranscutaneous analyte measurement system 10 includes a continuousglucose sensor and comprises a subcutaneous sensor such as describedwith reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al. or U.S.Pat. No. 6,484,046 to Say et al., for example. In another embodiment,the transcutaneous analyte measurement system 10 includes a continuousglucose sensor and comprises a subcutaneous sensor such as describedwith reference to U.S. Pat. No. 6,512,939 to Colvin et al. In anotherembodiment, the transcutaneous analyte measurement system 10 includes acontinuous glucose sensor and comprises an intravascular sensor such asdescribed with reference to U.S. Pat. No. 6,477,395 to Schulman et al.,for example. In another embodiment, the transcutaneous analytemeasurement system 10 includes a continuous glucose sensor and comprisesan intravascular sensor such as described with reference to U.S. Pat.No. 6,424,847 to Mastrototaro et al. Other signal processing techniquesand glucose monitoring system embodiments suitable for use with theembodiments described herein are described in U.S. Patent PublicationNo. US-2005-0203360-A1 and U.S. Patent Publication No.US-2009-0192745-A1, the contents of which are hereby incorporated byreference in their entireties. The transcutaneous analyte sensor 24 mayextend through a housing that may maintain the sensor on the skin andmay provide for electrical connection of the transcutaneous analytesensor 24 to sensor electronics, which may be provided in theelectronics unit 26.

In still further embodiments, a system may be provided utilizingcomponents disclosed herein for use in applying a drug delivery device,such as an infusion device, to the skin of an individual. In suchembodiments, the system can include a catheter instead of, or inaddition to, a transcutaneous analyte sensor 24, the catheter beingconnected to an infusion pump configured to deliver liquid medicines orother fluids into the patient's body. In embodiments, the catheter canbe deployed into the skin in much the same manner as the transcutaneousanalyte sensor 24 would be, for example as described herein.

In one embodiment, the transcutaneous analyte sensor 24 may be formedfrom a wire or is in a form of a wire. For example, the transcutaneousanalyte sensor 24 may include an elongated conductive body, such as abare elongated conductive core (e.g., a metal wire) or an elongatedconductive core coated with one, two, three, four, five, or more layersof material, each of which may or may not be conductive. The elongatedtranscutaneous analyte sensor 24 may be long and thin, yet flexible andstrong. For example, in some embodiments, the smallest dimension of theelongated conductive body of the transcutaneous analyte sensor 24 isless than about 0.1 inches, less than about 0.075 inches, less thanabout 0.05 inches, less than about 0.025 inches, less than about 0.01inches, less than about 0.004 inches, or less than about 0.002 inches.The transcutaneous analyte sensor 24 may have a circular cross-section.In some embodiments, the cross-section of the elongated conductive bodycan be ovoid, rectangular, triangular, polyhedral, star-shaped,C-shaped, T-shaped, X-shaped, Y-Shaped, irregular, or the like. In oneembodiment, a conductive wire electrode is employed as a core. To cladsuch an electrode, one or two additional conducting layers may be added(e.g., with intervening insulating layers provided for electricalisolation). The conductive layers can be comprised of any suitablematerial. In certain embodiments, it can be desirable to employ aconductive layer comprising conductive particles (i.e., particles of aconductive material) in a polymer or other binder.

In certain embodiments, the materials used to form an elongatedconductive body of the transcutaneous analyte sensor 24 (e.g., stainlesssteel, titanium, tantalum, platinum, platinum-iridium, iridium, certainpolymers, and/or the like) can be strong and hard, and therefore areresistant to breakage. For example, in some embodiments, the ultimatetensile strength of the elongated conductive body may be from about 80kPsi to about 500 kPsi. In another example, in some embodiments, theYoung's modulus of the elongated conductive body is from about 160 GPato about 220 GPa. In still another example, in some embodiments, theyield strength of the elongated conductive body is from about 60 kPsi toabout 2200 kPsi. In some embodiments, the transcutaneous analyte sensor24 may have a small diameter that provides (e.g., imparts, enables)flexibility to these materials, and therefore to the transcutaneousanalyte sensor 24 as a whole. Thus, the transcutaneous analyte sensor 24can withstand repeated forces applied to it by surrounding tissue.

In addition to providing structural support, resiliency and flexibility,in some embodiments, the core (or a component thereof) of thetranscutaneous analyte sensor 24 provides electrical conduction for anelectrical signal from a working electrode to sensor electronics. Insome embodiments, the core may comprise a conductive material, such asstainless steel, titanium, tantalum, a conductive polymer, and/or thelike. However, in other embodiments, the core is formed from anon-conductive material, such as a non-conductive polymer. In yet otherembodiments, the core may comprise a plurality of layers of materials.For example, in one embodiment the core includes an inner core and anouter core. In a further embodiment, the inner core is formed of a firstconductive material and the outer core is formed of a second conductivematerial. For example, in some embodiments, the first conductivematerial is stainless steel, titanium, tantalum, a conductive polymer,an alloy, and/or the like, and the second conductive material isconductive material selected to provide electrical conduction betweenthe core and the first layer, and/or to attach the first layer to thecore (e.g., if the first layer is formed of a material that does notattach well to the core material). In another embodiment, the core isformed of a non-conductive material (e.g., a non-conductive metal and/ora non-conductive polymer) and the first layer is a conductive material,such as stainless steel, titanium, tantalum, a conductive polymer,and/or the like. The core and the first layer can be of a single (orsame) material, e.g., platinum. One skilled in the art appreciates thatadditional configurations are possible.

In certain embodiments, the electronics unit 26 may be releasablycoupled to the transcutaneous analyte sensor 24. The electronics unit 26may include electronic circuitry associated with measuring andprocessing the continuous analyte sensor data and may be configured toperform algorithms associated with processing and calibration of datafrom the transcutaneous analyte sensor 24. For example, the electronicsunit 26 may provide various aspects of the functionality of a sensorelectronics module as described in U.S. Patent Publication No.2009-0240120-A1 and U.S. Patent Publication No. 2012-0078071-A1 thecontents of which are hereby incorporated by reference in theirentireties. The electronics unit 26 may include hardware, firmware,and/or software that enable measurement of levels of the analyte via aglucose sensor, such as a transcutaneous analyte sensor 24. For example,the electronics unit 26 may include a potentiostat, a power source forproviding power to the transcutaneous analyte sensor 24, othercomponents useful for signal processing and data storage, and preferablya telemetry module for one- or two-way data communication between theelectronics unit 26 and one or more receivers, repeaters, and/or displaydevices, such as devices 16, 18, 20, 22. Electronics can be affixed to aprinted circuit board (PCB), or the like, and can take a variety offorms. For example, the electronics can take the form of an integratedcircuit (IC), such as an Application-Specific Integrated Circuit (ASIC),a microcontroller, and/or a processor. The electronics unit 26 mayinclude sensor electronics that are configured to process sensorinformation, such as storing data, analyzing data streams, calibratinganalyte sensor data, estimating analyte values, comparing estimatedanalyte values with time corresponding measured analyte values,analyzing a variation of estimated analyte values, and the like.Examples of systems and methods for processing sensor analyte data aredescribed in more detail herein and in U.S. Pat. Nos. 7,310,544,6,931,327, U.S. Patent Publication No. 2005-0043598-A1, U.S. PatentPublication No. 2007-0032706-A1, U.S. Patent Publication No.2007-0016381-A1, U.S. Patent Publication No. 2008-0033254-A1, U.S.Patent Publication No. 2005-0203360-A1, U.S. Patent Publication No.2005-0154271-A1, U.S. Patent Publication No. 2005-0192557-A1, U.S.Patent Publication No. 2006-0222566-A1, U.S. Patent Publication No.2007-0203966-A1 and U.S. Patent Publication No. 2007-0208245-A1, thecontents of which are hereby incorporated by reference in theirentireties.

One or more repeaters, receivers and/or display devices, such as key fobrepeater 16, medical device receiver 18 (e.g., insulin delivery deviceand/or dedicated glucose sensor receiver), smart phone 20, portablecomputer 22, and the like are operatively linked to the electronics unit26, which receive data from the electronics unit 26 and in someembodiments transmit data to the electronics unit 26. For example, thesensor data can be transmitted from the sensor electronics unit 26 toone or more of key fob repeater 16, medical device receiver 18, smartphone 20, portable computer 22, and the like. In one embodiment, arepeater, receiver and/or display device may include an input modulewith a quartz crystal operably connected to an RF transceiver (notshown) that together function to transmit, receive and synchronize datastreams from the electronics unit 26. However, the input module can beconfigured in any manner that is capable of receiving data from theelectronics unit 26. Once received, the input module sends the datastream to a processor that processes the data stream, such as describedin more detail below. The processor is the central control unit thatperforms the processing, such as storing data, analyzing data streams,calibrating analyte sensor data, estimating analyte values, comparingestimated analyte values with time corresponding measured analytevalues, analyzing a variation of estimated analyte values, downloadingdata, and controlling the user interface by providing analyte values,prompts, messages, warnings, alarms, and the like. The processorincludes hardware that performs the processing described herein, forexample read-only memory (ROM) provides permanent or semi-permanentstorage of data, storing data such as sensor ID (sensor identity),receiver ID (receiver identity), and programming to process data streams(for example, programming for performing estimation and other algorithmsdescribed elsewhere herein) and random access memory (RAM) that storesthe system's cache memory and is helpful in data processing. An outputmodule, which may be integral with and/or operatively connected with theprocessor, includes programming for generating output based on thesensor data received from the electronics unit (and any processing thatincurred in the processor).

In some embodiments, analyte values are displayed on a display device.In some embodiments, prompts or messages can be displayed on the displaydevice to convey information to the user, such as reference outliervalues, requests for reference analyte values, therapy recommendations,deviation of the measured analyte values from the estimated analytevalues, or the like. Additionally, prompts can be displayed to guide theuser through calibration or trouble-shooting of the calibration.

Additionally, data output from the output module can provide wired orwireless, one- or two-way communication between the receiver and anexternal device. The external device can be any device that interfacesor communicates with the receiver. In some embodiments, the externaldevice is a computer, and the receiver is able to download current orhistorical data for retrospective analysis by a physician, for example.In some embodiments, the external device is a modem, and the receiver isable to send alerts, warnings, emergency messages, or the like, viatelecommunication lines to another party, such as a doctor or familymember. In some embodiments, the external device is an insulin pen, andthe receiver is able to communicate therapy recommendations, such asinsulin amount and time, to the insulin pen. In some embodiments, theexternal device is an insulin pump, and the receiver is able tocommunicate therapy recommendations, such as insulin amount and time tothe insulin pump. The external device can include other technology ormedical devices, for example pacemakers, implanted analyte sensorpatches, other infusion devices, telemetry devices, or the like. Thereceiver may communicate with the external device, and/or any number ofadditional devices, via any suitable communication protocol, includingradio frequency, Bluetooth, universal serial bus, any of the wirelesslocal area network (WLAN) communication standards, including the IEEE802.11, 802.15, 802.20, 802.22 and other 802 communication protocols,ZigBee, wireless (e.g., cellular) telecommunication, paging networkcommunication, magnetic induction, satellite data communication, GPRS,ANT, and/or a proprietary communication protocol.

The transcutaneous analyte measurement system 10 may be inserted intothe skin of an individual by use of an applicator for the transcutaneousanalyte sensor system. The transcutaneous analyte sensor system may bein form of an on-skin sensor assembly 12, as discussed in regard to FIG.1.

FIG. 2 illustrates an embodiment of a system 100 for inserting atranscutaneous analyte sensor into an individual's skin. The system 100may be configured to deploy an on-skin sensor assembly to theindividual's skin. The system 100 may include an applicator 102 and mayinclude a cartridge 104 configured to couple with the applicator 102.The cartridge 104 may be configured to retain all or a portion of thetranscutaneous analyte sensor system (e.g., an on-skin sensor assembly12) prior to deployment to the individual's skin.

FIG. 3, for example, illustrates components of a transcutaneous analytesensor system that may be retained by the cartridge 104. The componentsmay include a patch 106 and a housing for the on-skin sensor assembly (awearable housing 108). The patch 106 may comprise an adhesive patch thatmay be utilized to adhere the wearable housing 108 to the individual'sskin. The patch 106 may extend radially outward from the wearablehousing 108 and may surround the wearable housing 108. The patch 106 mayhave a disk shape, or other shapes as desired. The patch 106 may be madeof a flexible material, such as a cloth, or a polymer material, or acombination thereof, among other types of flexible materials. The patch106 may have an adhesive surface for being applied to the individual'sskin. The wearable housing 108 may include a receiver 110 for couplingto an electronics unit 26, which may include a communications devicesuch as a transmitter, and may include other electronics of thetranscutaneous analyte sensor system. The electronics unit 26 may becoupled to the wearable housing 108 to couple the electronics unit 26 tothe transcutaneous analyte sensor 24. The receiver 110 may comprise acavity in the wearable housing 108 for receiving the electronics unit26.

Other components of the transcutaneous analyte sensor system may includethe transcutaneous analyte sensor 24 and the electronics unit 26. FIG.4, for example, illustrates an exploded view of a transcutaneous analytesensor system, in the form of an on-skin sensor assembly, showing thetranscutaneous analyte sensor 24 and the electronics unit 26. Thetranscutaneous analyte sensor 24, as shown in FIG. 4, may comprise awire, and may have a sensing portion 112 and a contact portion 114. Thesensing portion 112 may be configured to be under the individual's skinfor sensing the analyte and the contact portion 114 of thetranscutaneous analyte sensor 24 may be configured to be electricallyconnected to the electronics unit 26. The transcutaneous analyte sensor24 may be configured to be positioned between the patch 106 and thewearable housing 108. The sensing portion 112 may extend downward,transverse to the plane that the wearable housing 108 extends in, andmay extend through an opening 116 in the patch 106. The contact portion114 may extend parallel to the plane that the wearable housing 108extends in, and may be configured to engage a coupler that allowselectrical signals from the contact portion 114 to be provided to theelectronics unit 26.

The electronics unit 26 may operate as disclosed herein and may beconfigured to be inserted into the receiver 110 of the wearable housing108. The electronics unit 26 may be configured to include a coupler 118in the form of a tab (as shown in FIG. 4), or in another form as desiredfor coupling to the wearable housing 108. The tab may slide into acavity of the wearable housing 108 having a corresponding shape. Theelectronics unit 26 may be configured to receive electrical signals fromthe contact portion 114 of the transcutaneous analyte sensor 24.

The electronics unit 26 may be configured to be separable from thewearable housing 108, such that the wearable housing 108 may be appliedto the skin of the individual and the transcutaneous analyte sensor 24may be inserted into the skin of the individual without the electronicsunit 26 being coupled to the wearable housing 108. The electronics unit26 may later be coupled to the wearable housing 108 after the wearablehousing 108 is applied to the skin of the individual and thetranscutaneous analyte sensor is inserted into the skin of theindividual. The coupler 118 may be utilized to couple the electronicsunit 26 to the housing 108. In embodiments, the wearable housing 108 maybe applied to the skin of the individual and the transcutaneous analytesensor 24 may be inserted into the skin of the individual with theelectronics unit 26 coupled to the wearable housing 108.

The electronics unit 26 may be removably coupled to the wearable housing108 such that the electronics unit 26 may be removed from the wearablehousing 108 when the wearable housing 108 is to be replaced. Forexample, after a certain period of wear of the transcutaneous analytesensor system, the transcutaneous analyte sensor 24, the patch 106, andthe wearable housing 108 may be removed from the individual's body inorder to be discarded. The transcutaneous analyte sensor 24, the patch106, and the wearable housing 108 accordingly may be disposable and maybe intended for a single implantation. The electronics unit 26accordingly may be removed from the wearable housing 108 at a time fordisposal of the wearable housing 108, such that the electronics unit 26may be used again with a different wearable housing. The electronicsunit 26 as such may be for repeated use and the transcutaneous analytesensor 24, the patch 106, and the wearable housing 108 may be for singleuse. The electronics unit 26 may be removable from the wearable housing108 for a variety of other reasons, including recharge of a batterycontained in the electronics unit 26, replacement of a battery containedin the electronics unit 26, download of data from the electronics unit26 to an external device, or another reason as desired. In embodiments,the electronics unit 26 may be integral with the wearable housing 108and may be configured to comprise a disposable or single use electronicsunit 26 that is disposed along with the transcutaneous analyte sensor24, the patch 106, and the wearable housing 108. In embodiments, theelectronics unit 26 may be releasably coupled with the housing 108 yetmay be configured to comprise a disposable or single use electronicsunit 26 that is disposed along with the transcutaneous analyte sensor24, the patch 106, and the wearable housing 108. For example, theelectronics unit 26 may be separated from the wearable housing 108during implantation of the transcutaneous analyte sensor 24, and thencoupled to the wearable housing 108 following implantation of thetranscutaneous analyte sensor 24. The electronics unit 26 though may bediscarded along with the transcutaneous analyte sensor 24, the patch106, and the wearable housing 108.

Referring back to FIG. 3, further components of the system 100 may beretained by the cartridge 104. Such components may include a needle 120,which may include a needle shaft 122 and a needle hub 124. The needleshaft 122 may include a penetrating tip 126 at a distal end of theneedle shaft 122 and may have the needle hub 124 positioned at aproximal end of the needle shaft 122. The needle hub 124 may includecoupling members 128 that may be configured to engage a releasablecoupler. The coupling members 128 as shown in FIG. 3 may compriseprotrusions extending from the needle hub 124. The protrusions mayextend into a guide channel 130 of a needle cover 132, to guide themovement of the needle 120 within a slide channel 134 of the needlecover 132. For example, the protrusions may prevent undesired axialrotation of the needle 120 within the slide channel 134. In otherembodiments, the coupling members 128 may have a different form, forexample, the coupling members 128 may comprise cavities in the needlehub 124, or other shapes of protrusions, or even magnetically couplingstructures in an embodiment in which a magnetic coupler is utilized. Avariety of forms of coupling members 128 may be utilized.

A needle cover 132 may be retained by the cartridge 104. The needlecover 132 may have a distal end coupled to a portion of the wearablehousing 108 and a proximal end extending away from the wearable housing108 in a direction transverse to a plane that the wearable housing 108extends in. The needle cover 132 may be configured to be separable fromthe wearable housing 108. The needle cover 132 may extend upward fromthe wearable housing 108 and have a column shape as shown in FIG. 3. Theneedle cover 132 may comprise a body forming a sheath configured toextend over at least a portion of the needle 120 when the needle 120 isretracted into the needle cover 132 as disclosed herein. The needle 120may be configured to be moved relative to the needle cover 132 to bepositioned into the needle cover 132. The needle cover 132 may include aslide channel 134 positioned centrally in the cover body and configuredfor the needle 120 to slide in, particularly in a proximal direction.The needle cover 132 may be configured to cover at least a portion ofthe needle 120 following the needle 120 guiding the transcutaneousanalyte sensor into the skin of the individual.

The needle cover 132 may include one or more guide channels 130 (asimilar guide channel 130 is located on the opposite side of the cover132) for the coupling members 128 of the needle hub 124 to slide along.The needle cover 132 may include locks 136 that may be part of the bodyof the needle cover 132 and may extend inward towards the slide channel134. The locks 136 may be configured to lock to and engage lockingmembers 138 (marked in FIG. 26) of the needle hub 124. The engagement ofthe lock 136 with the locking members 138 may hold the needle 120 inposition within the slide channel 134 when the needle 120 is retractedwithin the slide channel 134. The lock 136 may hold the needle 120within the slide channel 134 such that the needle cover 132 covers thepenetrating tip 126, such that an individual cannot contact thepenetrating tip 126 upon retraction of the needle 120 into the slidechannel 134. The locking members 138 may comprise contoured surfaces ofthe needle hub 124 or may have another configuration as desired.

The proximal end of the needle cover 132 may include an opening 140 thatis configured to receive a release actuator configured to release theneedle 120 and the needle cover 132 from a releasable coupler, andaccordingly from the applicator, as disclosed herein.

The needle cover 132 may be configured to separate from the wearablehousing 108 at a desired time, with the distal end of the needle cover132 being removed from the wearable housing 108. The needle cover 132when positioned in the cartridge 104, however, may be in a configurationas shown in FIG. 3 and coupled to the wearable housing 108.

FIG. 5 shows an exploded view of an assembly of components of thecartridge 104. The cartridge 104 may include a body 142 having a base144 and a wall 146. The body 142 may be configured to be coupled to theapplicator housing. The base 144 may form a bottom of the cartridge 104that the cartridge 104 may be positioned upon. As shown in FIG. 5, thebase 144 may form a flange extending outward from the wall 146. The wall146 may extend upward from the base 144, transverse to a direction thatthe base 144 extends in. The wall 146 may extend around and define acavity 148 that may receive components of the cartridge including thetranscutaneous analyte sensor 24 and the needle 120. The wall 146 mayextend around at least a portion of the needle cover 132. The wall 146may extend upward to an upper opening 149 that exposes the componentsretained by the body 142. The wall 146 may including an inner surfaceconfigured to face inward towards a central portion of the cartridge 104and the transcutaneous analyte sensor 24 may include an outer surfacefacing opposite the inner surface. The outer surface of the wall may beconfigured to be positioned within at least a portion of an applicator.The outer surface of the wall may comprise a mating surface for areceiver of the applicator, and may be contoured to a shape of an innersurface of the receiver of the applicator.

The wall 146 may have a shape that is configured to be inserted into areceiver of an applicator, and may be shaped such that only certainorientations of the cartridge 104 relative to the receiver of theapplicator may allow for coupling of the cartridge 104 to theapplicator. For example, the outer surface of the wall 146 may have anasymmetric contour in at least one dimension, such as an ovoid shape,that only allows for mating in a single rotational orientation betweenthe cartridge 104 and the applicator. In embodiments, for example, asshown in FIG. 5, a protrusion 150 may be positioned on the outer surfaceof the cartridge 104 and may extend in an axial direction. Theprotrusion 150 may be utilized to allow the cartridge 104 to align withthe receiver of the applicator in the correct rotational orientation.The protrusion 150 may be configured to fit within a complementaryshaped channel of the applicator. The shape of the cartridge or theprotrusion may comprise a keyed portion of the cartridge configured toalign the cartridge with the receiver in a single rotationalorientation.

The body 142 may include a retainer 152 (marked in FIG. 21) that isconfigured to retain the transcutaneous analyte sensor 24, the wearablehousing 108, and the patch 106, and the other components coupled theretoincluding the needle 120 and the needle cover 132. The retainer 152 maycomprise a recess within the body 142 that the transcutaneous analytesensor 24, the wearable housing 108, and the patch 106 are positionedwithin. The recess may be shaped to the outer contour shape of the patch106 to prevent the patch 106 and wearable housing 108 from rotatingwithin the body 142. In other embodiments, other forms of retainers 152may be utilized, such as clasps, clips, pins, or other forms ofretainers. The retainer 152 may at least retain the transcutaneousanalyte sensor 24, the wearable housing 108, and the patch 106 such thatthe wall 146 extends around at least a portion of one or more of thetranscutaneous analyte sensor 24, the wearable housing 108, the patch106, the needle 120, and the cover 132. The inner surface of the wallmay be configured to face inward towards the transcutaneous analytesensor 24 and the outer surface of the wall may be configured to faceopposite the transcutaneous analyte sensor 24.

Referring to FIG. 21, the body 142 of the cartridge 104 may include acentral cavity 155 that is configured to receive the needle 120 whenpositioned within the body 142 of the cartridge 104 and retained by theretainer 152.

Referring back to FIG. 5, the cartridge 104 may include a removablecover 154 that extends over a portion of the body 142. The removablecover 154 covers the upper opening 149 and may block access to thecomponents contained within the body 142. The cover 154 may have acylindrical shape as shown in FIG. 5, with a top surface 156 and a sidesurface 158 extending axially downward from the top surface 156. The topsurface 156 may be configured to be positioned over the upper opening149 and the side surface 158 may be configured to be positioned over theouter surface of the wall 146 when the removable cover 154 is positionedover the body 142. The side surface 158 may have a contoured portion 160that may be configured to extend over the protrusion 150 and may have ashape that is complementary to the shape of the protrusion 150.

The removable cover 154 may comprise a body, such as a canister body,having a height and a width and covers the needle cover 132. The sidesurface 158 of the removable cover 154 may be configured to have aheight such that the needle cover 132 may extend upward from thewearable housing 108 without being undesirably compressed by the topsurface 156 of the removable cover 154. The top surface 156 may have awidth corresponding to the width of the cartridge 104.

The removable cover 154 may be configured to form a hermetic seal of theupper opening 149, to seal the contents of the body 142 and preventmicrobes, or undesired human interaction with the interior of the body142 and the components contained therein. Thus, components such as theneedle 120 and the transcutaneous analyte sensor 24 that may be insertedinto an individual's skin may remain sterile within the body 142. Theremovable cover 154 may cover the contents of the cartridge 104,including the transcutaneous analyte sensor 24 and the needle 120 withinthe cartridge 104.

The components of the transcutaneous analyte sensor system may beretained by the body 142 prior to deployment to the individual's skin.Such components may or may not include the electronics unit 26, which isshown in FIG. 5, which ultimately may be provided separately from thecartridge 104 and coupled to the wearable housing 108 after deploymentof the wearable housing 108 to the individual's skin. The needle 120 andneedle cover 132 may be retained by the body 142 and positioned underthe removable cover 154. A variety of other components may be retainedby the body 142 as desired.

FIG. 6 illustrates a perspective view of the cartridge 104 including theremovable cover 154 in position. The cartridge 104 may be provided as aunit that is supplied to an individual for use with a transcutaneousanalyte sensor applicator. The unit may comprise a sealed unit thatretains the contents in a sterile condition prior to deployment of thetranscutaneous analyte sensor system. The removable cover 154 may beremoved and then discarded. The body 142 of the cartridge 104 may beconfigured to be coupled to an applicator for the components of thetranscutaneous analyte sensor system to be deployed to the individual'sskin. The body 142 of the cartridge may be discarded, and if anothertranscutaneous analyte sensor system is desired to be deployed to theindividual's skin, then another cartridge 104 may be utilized. As such,multiple cartridges may be utilized with the applicator, with componentsof the cartridges being discarded after use.

FIG. 7 illustrates an exploded perspective view of the applicator 102shown in FIG. 2. The applicator 102 comprises a transcutaneous analytesensor applicator, and is configured to apply other components of thetranscutaneous analyte sensor system to the skin of an individualincluding the wearable housing 108 and patch 106 of the transcutaneousanalyte sensor system. The applicator may deploy all or a portion ofcomponents of an on-skin sensor assembly 12 to an individual's skin.

The applicator 102 comprises a reusable applicator, which may berepeatedly utilized for deployment of transcutaneous analyte sensor, aswell as other components of a transcutaneous analyte sensor system. Assuch, the applicator 102 may not be intended to be discarded after asingle use, and comprise a multi-use applicator. The applicator 102however may be configured to deploy transcutaneous analyte sensors, aswell as other components of a transcutaneous analyte sensor system thatmay be intended for a single use. The applicator 102 may be configuredto be reloaded with multiple different transcutaneous analyte sensors,and other components of a transcutaneous analyte sensor systems, forrepeated deployment of the multiple different components.

FIG. 7 illustrates components of the applicator 102. The applicator 102may include an applicator housing 162, which may comprise a singlecomponent or multiple components. As shown in FIG. 7, the applicatorhousing 162 may include side cover bodies 164 a, b, a lower body 166, anupper body 168, and a support body 170. The components of the applicatorhousing 162 may be coupled together to form a single applicator housing162. The applicator housing 162 may be configured to be gripped by anindividual to apply the transcutaneous analyte sensor into theindividual's skin, to be held during deployment of the transcutaneousanalyte sensor, as well as other components of a transcutaneous analytesensor system. As shown in FIG. 2, for example, the applicator housing162 may have a cylindrical shape with an outer surface configured to begripped by an individual. Other shapes of the applicator housing 162 maybe utilized as desired.

The applicator housing 162 may include a side portion (formed by theside cover bodies 164 a, b), a top portion (formed by the control device178) and a bottom portion including an opening 280 shown in FIG. 21 forthe transcutaneous analyte sensor to be deployed from to be insertedinto the individual's skin. The opening 280 may be configured for theneedle 120 and the transcutaneous analyte sensor 24 to pass through toinsert the transcutaneous analyte sensor 24 into the individual's skin.

FIG. 7 illustrates other components of the applicator 102. Thecomponents may include an actuator that may be coupled to the applicatorhousing 162 and is configured to insert the needle 120 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. Such an actuator may be referred to as aninsertion actuator. The insertion actuator may include components thatmay include a control device 172 and a driver 174, and may include acarriage 176. The insertion actuator may include other components (orfewer components) in other embodiments. The applicator 102 may include arelease actuator that is configured to release the needle 120 from areleasable coupler. The release actuator may include components that mayinclude a control device 178 and may include a pressing surface 180(marked in FIG. 18) that is configured to apply a force to thereleasable coupler to cause the needle 120 to release from thereleasable coupler. The release actuator may be configured to releasethe needle 120 from the releasable coupler to allow the needle 120 to bepassed through the opening 280 at the bottom portion of the applicatorhousing. The release actuator may include other components (or fewercomponents) in other embodiments. The applicator 102 may include aretraction actuator that is configured to retract the needle 120 fromthe individual's skin following insertion of the transcutaneous analytesensor into the individual's skin. The retraction actuator may includecomponents that may include a driver 182 and a carriage 184. Theretraction actuator may include other components (or fewer components)in other embodiments. The configuration of components in the applicator102 may be varied in other embodiments.

FIG. 8 illustrates a perspective view of the carriage 176 of theinsertion actuator. The carriage 176 may comprise a body configured toslide within an interior cavity of the applicator 102 that may bedefined by the applicator housing 162. The carriage 176 may beconfigured to slide relative to the applicator housing and be configuredto be slid by the driver 174 of the insertion actuator. The carriage 176may include an outer ring 202 having an outer surface 186 that mayinclude protrusions 188 that slide along channels 190 (marked in FIG.12) of the lower body 166 of the applicator housing 162. The position ofthe protrusions 188 within the channels 190 may prevent the carriage 176from undesirably rotating axially within the applicator housing 162. Theprotrusions 188 may be spaced from each other on the outer surface 186of the carriage 176.

The outer ring 202 of the carriage 176 may include an upper surface 192that spans between the outer surface 186 of the carriage 176 and aninner surface 194 of the outer ring 202 of the carriage 176. Stops 196may protrude upward from the upper surface 192 of the carriage 176 forcontacting a portion of the release actuator and impeding movement ofthe portion of the release actuator.

The inner surface 194 may face opposite the outer surface 186 and maysurround a cavity 198 of the carriage 176. The cavity 198 may beconfigured to receive the carriage 184 of the retraction actuator andmay be configured to receive a driver 182 of the retraction actuator.

The carriage 176 may include a central body 200 (marked in FIG. 21) thatspans the interior of the outer ring 202 (marked in FIG. 21) of thecarriage 176. The outer ring 202 may include a channel 203 (marked inFIG. 21) configured to receive the wall 146 of the cartridge 104. Achannel 205 (marked in FIG. 21) may extend circumferentially around thecentral body 200 between the central body 200 and the outer ring 202.The channel 205 may be configured to receive the driver 174 of theinsertion actuator.

An upper surface of the central body 200 may include a releasablecoupler 204 configured to couple to a coupling member of the insertionactuator. The releasable coupler 204 may comprise a U-shaped body havinga central opening that the coupling member, which may be in the form ofa ledge, is configured to extend into. The U-shaped body extends upwardfrom the central body 200 and is configured to be deflectable to bendoff of the ledge of the insertion actuator, to release the releasablecoupler 204 from the ledge. In other embodiments, the releasable coupler204 may have different forms.

Referring to FIG. 8, one or more arms 206 a, b may extend upward fromthe central body 200 of the carriage 176 and may include releasablecouplers 208 a, b that are configured to couple with portions of thecarriage 184 of the retraction actuator. The releasable couplers 208 a,b may comprise protrusions as shown in FIG. 8, yet in other embodimentsmay have other configurations. Coupler releases in the form ofdeflectors 210 a, b may be coupled to the respective arms 206 a, b andmay be configured to deflect the arms 206 a, b in a direction transverseto the axial dimension of the applicator 102 to release the releasablecouplers 208 a, b in a manner disclosed herein.

Referring to FIG. 21, a lower surface of the central body 200 mayinclude a receiver 212 that is configured to receive at least a portionof the transcutaneous analyte sensor system. The receiver 212 maycomprise a cavity that is configured to receive the transcutaneousanalyte sensor system. As shown in FIG. 21, the receiver 212 may includeat least one releasable coupler 214 that is configured to couple to thewearable housing 108 of the transcutaneous analyte sensor system. Thereleasable coupler 214 may comprise a protrusion configured to enterinto a cavity 123 (marked in FIG. 3) of the wearable housing 108 tocouple to the wearable housing 108. In other embodiments, other forms ofreleasable couplers 214 may be utilized.

Referring to FIG. 21, an opening 216 may be positioned on the centralbody 200 and may extend through the lower surface of the central body200 to the upper surface of the central body 200. The opening 216 may beconfigured for the needle cover 132 to pass through.

The configuration of the carriage 176 may be varied in otherembodiments.

FIG. 8 represents an assembly view of the carriage 176, with the driver182 of the retraction actuator shown in position within the cavity 198of the carriage 176. The driver 182 may comprise a device for drivingthe carriage 184 and driving the retraction actuator, and may beconfigured to provide a motive force to cause the carriage 184 to slidewithin the applicator housing 162. The driver 182 may be configured todrive the needle 120 out of the individual's skin. The driver 182 maycomprise a spring as shown in FIG. 8. The spring may be configured to beprovided with energy that compresses the spring, upon which the springexerts a responsive force that releases the energy and expands thespring. The spring may be a helical spring as shown in FIG. 8, or inother embodiments other configurations of springs or other drivers maybe utilized as desired.

FIG. 9 illustrates a bottom perspective view of the carriage 184 of theretraction actuator. The carriage 184 may be configured to sliderelative to the applicator housing and be configured to be slid by thedriver 182 and driver 174. The lower surface of the carriage 184 mayinclude a releasable coupler 218 that is configured to retain the needle120 at least partially within the applicator housing 162 followinginsertion of the transcutaneous analyte sensor 24 into the individual'sskin and removal of the applicator housing 162 from the transcutaneousanalyte sensor 24, and configured to release the needle 120 from withinthe applicator housing 162 following insertion of the transcutaneousanalyte sensor 24 into the individual's skin. As shown in FIG. 9, thereleasable coupler 218 may include one or more protrusions 219 a, b thatare configured to releasably couple to the needle 120, particularly thecoupling members 128 of the needle hub 124 shown in FIG. 3. Theprotrusions 219 a, b may overlap the surfaces of the coupling members128 to couple to the coupling members 128. The protrusions 219 a, b maybe angled such that the protrusions 219 a, b slide over angled portionsof the coupling members 128 to couple to the coupling members 128.

The releasable coupler 218 may include respective arms 220 a, b coupledto the protrusions 219 a, b and having the protrusions 219 a, b at theirdistal ends. The arms 220 a, b may be configured to be deflectable toallow the protrusions 219 a, b to decouple from the needle 120 torelease the needle 120. The arms 220 a, b may be positioned on sides ofa central channel that allows the needle cover 132 and the needle 120 topass between the arms 220 a, b. In other embodiments, otherconfigurations of a releasable coupler 218 may be utilized.

FIG. 10 illustrates a top perspective view of the carriage 184 of theretraction actuator, while being slid over the arms 206 a, b of thecarriage 176 of the insertion actuator. An upper surface of the carriage184 is visible, showing an opening 222 surrounding the central channelthat allows the needle cover 132 and the needle 120 to passtherethrough. An opening 224 is visible that allows the releasablecoupler 204 of the insertion actuator to pass therethrough. Openings 226a, b allow the arms 206 a, b of the carriage 176 of the insertionactuator to pass therethrough.

The carriage 184 is shown to include arms 228 a, b that extend upwardfrom the upper surface in the axial dimension. The arms 228 a, b eachinclude respective channels 230 a, 230 b that the releasable couplers208 a, 208 b are configured to extend into. The arms 228 a, b mayinclude coupling members 232 a, b within the respective channels 230 a,230 b that couple to the respective releasable couplers 208 a, 208 b.The coupling members 232 a, b may comprise ledges for the releasablecouplers 208 a, 208 b to rest upon. The releasable couplers 208 a, 208 bmay be configured to be deflected in a direction transverse to the axialdimension (e.g., each in a direction laterally outward from the centerof the carriage 184) to release from the coupling members 232 a, b.

FIG. 10 shows an assembly view of the carriage 184 of the retractionactuator being positioned upon the carriage 176 of the insertionactuator with the driver 182 of the retraction actuator being positionedbetween the lower surface of the carriage 184 and the upper surface ofthe carriage 176. The driver 182 may be compressed and energized betweenthe carriages 184, 176. The carriages 184, 176 may be slid towards eachother to cause the releasable couplers 208 a, 208 b of the arms 206 a, bto couple to the respective coupling members 232 a, b of the arms 228 a,b. FIG. 11, for example, illustrates such a configuration, with thecarriage 184 of the retraction actuator being releasably coupled to thecarriage 176 of the insertion actuator.

Referring to FIG. 12, the coupled carriage 184 of the retractionactuator and carriage 176 of the insertion actuator may be inserted intoa portion of the applicator housing, namely the lower body 166 of theapplicator housing 162. The lower body 166 may include a cavity 234 thatthe carriages 184, 176 are positioned within. The protrusions 188 on theouter surface of the carriage 176 may slide within the channels 190 ofthe lower body 166.

The driver 174 of the insertion actuator may be positioned within thecavity 234 and placed within the channel 205 of the carriage 176 shownin FIG. 21. The driver 174 may be configured similarly as the driver 182discussed in regard to the retraction actuator, and may comprise adevice for driving the carriage 176 as well as the carriage 184 anddriving the insertion actuator. The driver 174 may be configured toprovide a motive force to cause both the carriages 176, 184 to slidewithin the applicator housing 162. The driver 174 may be configured todrive the needle 120 into the individual's skin to insert thetranscutaneous analyte sensor into the individual's skin. The driver 174may comprise a spring as shown in FIG. 12. The spring may be configuredto be provided with energy to compress the spring, upon which the springexerts a responsive force that releases the energy and expands thespring. The spring may be a helical spring as shown in FIG. 12, or inother embodiments other configurations of springs or drivers may beutilized as desired.

Referring to FIG. 13, the upper body 168 may be positioned over thelower body 166 and may include a spring support body 236 that serves tocompress or provide an opposing force to the driver 174 as the driver174 is compressed. The upper body 168 may be coupled to the lower body166. The upper body 168 may define a cavity 238 configured to receive atleast a portion of the release actuator. The upper body 168 may includea spring support body 240 configured to compress or provide an opposingforce to a spring for biasing the control device 172 of the insertionactuator. The upper body 168 may include an opening 169 on the side ofthe applicator housing for the control device 172 to extend through. Theupper body may include an upper opening 171 at the top of the applicatorhousing for receiving a control device of the release actuator.

FIG. 14 illustrates a top perspective view of the upper body 168 coupledto the lower body 166. The arms 206 a, b, and arms 228 a, b extendthrough respective openings 242 a, b in the spring support body 236. Thespring support body 236 may include an opening 244 for the releasablecoupler 204 of the insertion actuator to extend through, to couple tothe ledge 246 of the upper body 168.

FIG. 15 illustrates a perspective view of the control device 172 of theinsertion actuator. The control device 172 may be configured to beoperated by an individual. The control device 172 may comprise a buttonor other form of body that may be moved to activate the insertionactuator. The control device 172 may include a button surface 248 and acontrol arm 250 that extends from the button surface 248. The controlarm 250 may include a coupler release in the form of a contact surface252 that is configured to contact the releasable coupler 204 of theinsertion actuator, to release the releasable coupler 204 from the ledge246. The control arm 250 may also include a coupler release in the formof a contact surface 254 that the deflectors 210 a, b may contact at thedesired time to release the releasable couplers 208 a, b that couple thecarriages 176, 184 together. The contact surface 252 may comprise a hookstructure or downward extending surface, and the contact surface 254 maycomprise one or more protrusions extending laterally from the controlarm 250. The control arm 250 may further comprise a releasable couplerin the form of a lock 256 at a portion of the control arm 250 distal thebutton surface 248, configured to lock the control device 172 inposition.

FIG. 16 illustrates an assembly view of the control device 172 beinginserted through the opening 169 of the upper body 168. A portion of thecontrol arm 250 distal the button surface 248 may extend distally pastthe arm 228 b. The coupler release in the form of contact surface 254does not yet contact the deflector 210 b.

A biasing spring 258 may be provided that presses against the surface ofthe spring support body 240 and an inner surface of the button, to biasthe control device 172 in a direction away from the surface of thespring support body 240.

FIG. 17 illustrates a top perspective view of the support body 170 beingpositioned over the control device 172. The support body 170 may bepositioned within the cavity 238 of the upper body 168 and may define acavity 260 configured to receive at least a portion of the releaseactuator. The support body 170 may include a spring support surface 262that is configured to support a biasing spring of the release actuator.The support body 170 may also include a locking surface 264 configuredto engage the lock 256 of the control device 172.

FIG. 18 illustrates a bottom perspective view of the release actuator,showing the control device 178 and the pressing surface 180. The controldevice 178 may comprise a button or other form of body that may be movedby an individual to activate the release actuator. The control device178 may be coupled to the pressing surface 180, which may be configuredto press against the releasable coupler 218 shown in FIG. 9 to releasethe needle 120 from within the applicator housing 162. The pressingsurface 180 as shown in FIG. 18 may comprise a distal surface of acolumn 266 that extends axially from a button surface of the controldevice 178. The column 266 may surround an interior cavity 268 that maybe configured to receive a portion of the needle cover 132. The interiorcavity 268 may include a rod 270 having a pressing surface 272 at thedistal end of the rod 270, for pressing directly on the needle hub 124of the needle 120, to cause the needle 120 to release from theapplicator housing 162. The needle cover 132 accordingly may bepositioned between the rod 270 and the column 266 as the releaseactuator moves axially downward toward the needle 120.

The release actuator may further include a coupler release in the formof a lock release surface 274, which may comprise a protrusionconfigured to release the lock 256 of the control device 172 from thelocking surface 264.

As shown in FIG. 19, the release actuator may be inserted into thecavity 238 of the upper body 168. A biasing spring 276 may be positionedbetween the control device 178 and the spring support surface 262 shownin FIG. 17 to provide a biasing force in an upward direction for thecontrol device 178 and accordingly for the pressing surface 180.

FIG. 20 illustrates the side cover bodies 164 a, b extending over thesides of the lower body 166 and the upper body 168 and forming the outersurface of the applicator housing 162. The side cover 164 a may includean opening 278 for the control device 172, such that the control device172 is accessible on a side surface of the applicator housing 162. Theside covers 164 a, b together may form an opening at the top of theapplicator housing 162 such that the control device 178 is accessible atthe top of the applicator housing, opposite an opening 280 (marked inFIG. 21) at the bottom of the applicator housing for receiving thecartridge 104 and for the transcutaneous analyte sensor 24 to bedeployed from.

Referring to FIG. 21, the applicator housing 162 may include a receiver282 for receiving the cartridge 104. The receiver may be configured forthe cartridge 104 retaining the transcutaneous analyte sensor to beinserted into. The receiver 282 may comprise a cavity within theapplicator housing 162 that receives the cartridge 104. The cartridge104 may be inserted into the receiver 282 axially through the opening280.

FIGS. 21-28 illustrate steps in a method of operating the system 100.FIG. 21 illustrates the applicator 102 in an initial state, in which theapplicator 102 is configured to receive the cartridge 104 and componentsof the transcutaneous analyte sensor system including the transcutaneousanalyte sensor 24, the wearable housing 108, and the patch 106. Theelectronics unit 26 is shown to be coupled to the wearable housing 108upon insertion into the receiver 282 of the applicator 102, however theelectronics unit 26 may be excluded and later coupled to the wearablehousing 108 as desired.

The applicator 102 in the initial state has the carriage 176 of theinsertion actuator in a lowered state, proximate the lower opening 280of the applicator 102. The carriage 176 of the insertion actuator may bepressed to the lowered state by the force provided by the driver 174 ofthe insertion actuator. The carriage 184 of the retraction actuator maybe in a raised state, pressed to the raised state by the force of thedriver 182 of the retraction actuator. The releasable couplers 208 a, bshown in FIG. 8 are not yet coupling the carriages 176, 184 together.

The cartridge 104 as shown in FIG. 21 has the removable cover 154 shownin FIG. 6, for example, removed to remove the hermetic seal of thecontents contained therein. The cartridge 104 may then be inserted intothe receiver 282 of the applicator housing 162 with the upper end of theneedle cover 132 passing through the opening 216 of the carriage 176 ofthe insertion actuator. The body of the cartridge 104 may be insertedinto the receiver 282 with the protrusion 150 fitting into acomplementary shaped channel 284 of the applicator housing 162, to alignthe desired axial rotation of the cartridge 104 with the applicator 102.

FIG. 22 illustrates the cartridge 104 fully inserted into the receiver282 of the applicator housing 162. The cartridge 104 may be inserted inthe axial dimension of the applicator housing 162, which is the samedimension that the transcutaneous analyte sensor 24 as well as othercomponents of the transcutaneous analyte sensor system will be deployedfrom the applicator housing 162 (although in an opposite axial directionthat the cartridge 104 is inserted into the receiver 282). The insertionof the cartridge 104 and the transcutaneous analyte sensor 24 into thereceiver 282 of the applicator housing 162 may compress and thus provideenergy to both the driver 174 of the insertion actuator and the driver182 of the retraction actuator. Both drivers 174, 182 are shown to becompressed in FIG. 22. In an embodiment in which the drivers 174, 182are springs, the springs may be compressed by the insertion of thecartridge 104 and the transcutaneous analyte sensor 24 into thereceiver. The cartridge 104 may include a pressing surface upon an uppersurface of the cartridge 104 to press against the carriage 176 of theinsertion actuator to provide energy to the insertion actuator.

The insertion of the cartridge 104 into the receiver 282 of theapplicator housing 162 also causes the releasable coupler 204 of theinsertion actuator to engage the coupling member, in the form of a ledge246, of the upper body 168. The engagement of the releasable coupler 204holds the carriage 176 of the insertion actuator in position andprevents the driver 174 from pressing the carriage 176 in an axialdirection towards the lower opening 280 of the applicator housing 162.The releasable couplers 208 a, b shown in FIG. 8 engage the couplingmembers 232 a, b of the carriage 184 of the retraction actuator tocouple the carriages 176, 184 together, producing a configuration asshown in FIG. 11.

The stops 196 protruding upward from the upper surface 192 of thecarriage 176 may contact a contact surface 286 of the release actuator(marked in FIG. 18) to impede downward movement and activation of therelease actuator. As such, the release actuator may be prevented fromoperating prematurely.

The wearable housing 108 of the transcutaneous analyte sensor system maybe positioned in the receiver 212 of the lower surface of the carriage176. The releasable coupler 214 shown in FIG. 21 may couple to thecavity 123 shown in FIG. 3 to grip the wearable housing 108 to the lowersurface of the carriage. Thus, as the cartridge 104 is withdrawn fromthe applicator housing 162, the wearable housing 108 remains coupled tothe receiver 212.

FIG. 23, for example, illustrates a front cross sectional view of theapplicator housing 162 in which the cartridge 104 has been removed fromthe applicator housing 162. The cartridge 104 may be gripped by theflange at the base 144 of the cartridge body, to pull the cartridge 104out of the applicator housing 162 in an opposite direction in which thecartridge 104 was inserted into the applicator housing 162.

The releasable coupler 218 is shown coupled to the needle 120,particularly with the protrusions 219 a, b of the releasable coupler 218shown in FIG. 9 engaging the coupling members 128 of the needle hub 124shown in FIG. 3. The needle 120 is shown to extend downward from thewearable housing 108 of the transcutaneous analyte sensor system,extending for insertion of the penetrating tip 126 of the needle 120into the individual's skin.

FIG. 24, for example, shows the needle 120 may extend axially along withthe sensing portion of the transcutaneous analyte sensor 24, such thatthe needle 120 upon insertion into the individual's skin may guide orinsert the sensing portion of the transcutaneous analyte sensor 24 intothe individual's skin.

Referring back to FIG. 23, the pressing surface 180 of the releaseactuator is shown to not yet be pressing against the releasable coupler218.

Referring to FIG. 24, with the cartridge 104 withdrawn from theapplicator housing 162, the transcutaneous analyte sensor system is inposition for application to the individual's skin by the applicator 102.The transcutaneous analyte sensor system may be moved axially downwardwithin the receiver of the applicator housing 162 to contact theindividual's skin and be applied to the individual's skin.

The insertion actuator may operate to insert the needle 120 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. FIG. 24 illustrates that the control device 172of the insertion actuator may be pressed in a lateral direction, or adirection transverse to the axial dimension of the applicator housing162. The movement of the control device 172 may compress the biasingspring 258. The control device 172 may disengage the releasable coupler204 from the ledge 246, to allow the coupled carriages 176, 184 to slideaxially downward within the applicator housing 162. The contact surface252 shown in FIG. 15 for instance may press against the upper “U”portion of the releasable coupler 204 to push the upper “U” portion offof the ledge 246. The force of the driver 174 upon the carriage 176causes the coupled carriages 176, 184 to descend rapidly with sufficientforce to drive the needle 120 into the individual's skin and insert thetranscutaneous analyte sensor 24 into the individual's skin.

Further as shown in FIG. 24, upon the control device 172 of theinsertion actuator being pressed in a lateral direction, the lockingsurface 264 of the support body 170 may engage the lock 256 of thecontrol device 172. The lock 256 may include an angled surface thatslides under the locking surface 264 to allow the lock 256 to bepositioned distal of the locking surface 264 and thus lock the lock 256in position. The lock 256 may prevent the control device 172 fromundesirably moving after the control device 172 has been pressed.

FIG. 25 illustrate the configuration of the coupled carriages 176, 184after the carriage 176 of the insertion actuator has been slid withinthe applicator housing 162 in a downward direction. The movement of thecarriage 176 has inserted the needle 120 into the individual's skin andhas inserted the transcutaneous analyte sensor 24 into the individual'sskin. Further, the movement of the carriage 176 has pressed the patch106 to the individual's skin, allowing the patch 106 to adhere to theindividual's skin and providing an adhesive force to the skin for thetranscutaneous analyte sensor system. The lower portion of theapplicator housing may be applied to and contact the individual's skinduring deployment of the transcutaneous analyte sensor system.

Further, with the carriages 176, 184 both being slid downward within theapplicator housing 162, the deflectors 210 a, b coupled to the arms 206a, b may contact the contact surfaces 254 shown in FIG. 15. Such contactmay apply a force to the deflectors 210 a, b in lateral directions thatcauses the releasable couplers 208 a, b on the arms 206 a, b todisengage from the coupling members 232 a, b of the arms 228 a, b and beable to slide within the channels 230 a, b of the arms 228 a, b (markedin FIG. 10). Accordingly, the carriages 176, 184 may be decoupled fromeach other and able to slide relative to each other. The retractionactuator accordingly may be configured to automatically operate upon theneedle 120 inserting the transcutaneous analyte sensor into theindividual's skin. The releasable couplers 208 a, b may be configured toautomatically release upon contact with the coupler release in the formof contact surfaces 254 shown in FIG. 15.

With the carriages 176, 184 decoupled from each other, the driver 182 ofthe retraction actuator may apply an upward force to the carriage 184 ofthe retraction actuator to move the carriage 184 upward.

Referring to FIG. 26, the upward movement of the retraction actuatorcarriage 184 may cause the needle 120 that is coupled to the releasablecoupler 218 to retract out of the individual's skin, due to the upwardmovement of the releasable coupler 218. The releasable coupler 218 maycause the needle 120 to retract into the needle cover 132, to besheathed within the needle cover 132. The retraction actuator mayposition the needle 120 into the needle cover 132. The releasablecoupler 218 may retract the needle 120 such that the needle 120 retractsso that the locks 136 shown in FIG. 3 engage the locking members 138 ofthe needle hub 124 and retain the needle 120 in position within theneedle cover 132. A flange 288 shown in FIG. 26 at an end of the needlecover 132 that extends through the opening 216 may impede further upwardmovement of the needle 120 and the needle cover 132 due to the upwardmovement of the releasable coupler 218.

Further, as shown in FIG. 26, the transcutaneous analyte sensor systemin the form of an on-skin sensor assembly may remain on the individual'sskin as the applicator 102 is withdrawn from the individual's skin andremoved and withdrawn from the transcutaneous analyte sensor 24. Thetranscutaneous analyte sensor system accordingly is no longer presentwithin the receiver 212. The releasable coupler 218 retains the needle120 to the applicator housing 162 following insertion of thetranscutaneous analyte sensor 24 into the individual's skin and removalfrom the applicator housing from the transcutaneous analyte sensor 24.The transcutaneous analyte sensor 24 remains within the individual'sskin as the applicator housing is removed from the transcutaneousanalyte sensor 24.

With the applicator housing removed from the transcutaneous analytesensor 24, the release actuator may be operated to release the needle120 from within the releasable coupler 218.

FIG. 27, for example, illustrates the control device 178 of the releaseactuator having been pressed axially downward, causing the column 266 ofthe release actuator to similarly move axially downward. The pressingsurface 180 of the release actuator accordingly may be moved axiallydownward to press against the releasable coupler 218 and particularlypress against the deflectable arms 220 a, b shown in FIG. 9. Thepressure of the pressing surface 180 against the deflectable arms 220 a,b causes the protrusions 219 a, b (marked in FIG. 9) to release from thecoupling members 128 of the needle hub 124. Accordingly, the releasablecoupler 218 may be released from the needle 120. Further, the pressingsurface 272 of the rod 270 shown in FIG. 18 may press against the needle120 (particularly the needle hub 124) to cause the needle 120 to releasefrom the applicator housing 162. The needle 120 may remain sheathedwithin the needle cover 132 during this process.

Further, as shown in FIG. 28, which is a side cross sectional view ofFIG. 27, the lock release surface 274 (marked in FIG. 18) may contactthe lock 256 of the control device 172, to press the lock 256 under thelocking surface 264. As such, the control device 172 may be free to movein the opposite lateral direction than shown in FIG. 24 and may be movedback to the position shown in FIG. 22 due to the force applied by thebiasing spring 258.

The release actuator may be configured to release the needle 120 coveredby the needle cover 132 from the applicator housing 162 followinginsertion of the needle into the individual's skin. The releasablecoupler 218 configured to retain the needle 120 is configured to releasethe needle 120 positioned within the needle cover 132 from within theapplicator housing. The release actuator may eject the needle 120 andthe needle cover 132 together as a unit that is configured for discard.The force of the pressing surface 272 of the rod 270 may eject the unittogether from the applicator housing 162 (i.e., release from theapplicator housing with velocity).

The needle 120 may be released from the applicator housing 162 fordiscard, as the needle 120 may have been contaminated through theprocess of insertion within the individual's skin. The needle 120accordingly may be a single use needle that is configured to discardwithin a sharps container or other disposal area. The needle 120 mayremain sheathed within the needle cover 132 such that an individual doesnot contact the used needle 120 and be subject to the contamination ofthe needle 120 or otherwise be injured by the penetrating tip of theneedle 120. The needle 120 may remain locked in position within theneedle cover 132 such that an individual cannot access the contaminatedportion of the needle 120. The needle 120 and needle cover 132 togethermay form a unit for disposal following insertion into an individual'sskin and separation from the applicator housing.

Referring to FIG. 28, upon release of the needle 120 and needle cover132 from the applicator housing 162 and following the return of thecontrol device 172 to the position shown in FIG. 24, the applicator isin a configuration for deployment of another transcutaneous analytesensor 24 and other components of a transcutaneous analyte sensorsystem. As such, the applicator 102 is configured for multiple uses, andis not intended to be discarded. The applicator 102 returns to aconfiguration shown in FIG. 21 for repeat of the steps shown in FIGS.21-28. The applicator 102 may be loaded with another cartridge 104 andthe steps shown in FIGS. 21-28 may repeat as desired.

FIG. 29 illustrates a side perspective view of a transcutaneous analytesensor system that may be deployed to an individual's skin 290 with theapplicator 102. The transcutaneous analyte sensor system is in the formof an on-skin sensor assembly 12. The transcutaneous analyte sensor 24is inserted into the skin of an individual. The patch 106 and wearablehousing 108 are visible, and an electronics unit may be incorporatedwithin the wearable housing 108. As discussed the electronics unit maybe integral with the wearable housing 108, or may be separable. All or aportion of the transcutaneous analyte sensor system may be configuredfor single use, and may be disposable. For example, as discussed, allcomponents of the transcutaneous analyte sensor system except theelectronics unit may be configured for single use, whereas in otherembodiments the entirety of the transcutaneous analyte sensor system maybe configured for single use. Other components of the transcutaneousanalyte sensor system may be configured to be reusable other than theelectronics unit.

Variations of the system 100 may be provided.

FIG. 30 illustrates an embodiment of a cartridge 300 that includes aneedle 302 having a needle cover 304 that is configured to slide touncover a portion of the needle 302 as the needle 302 is inserted intothe individual's skin. The needle cover 304 may be configured to slideaxially away from the penetrating tip 306 of the needle 302 to uncoverthe penetrating portion of the needle 302 as it is being inserted. Theneedle cover 304 may then be configured to slide axially towards thepenetrating tip 306 of the needle 302 to cover the needle 302 as theneedle 302 is retracted from the individual's skin. The needle 302 maybe configured to be moved relative to the needle cover 304 to bepositioned into the needle cover 304. The cover 304 accordingly mayprovide reciprocating axial motion along the needle 302.

As shown in FIG. 30, the cartridge 300 may be configured similarly asthe cartridge 104 shown in FIG. 5. The cartridge 300 may include a body308 having a base 310 and a wall 312. The base 310 may form a bottom ofthe cartridge 300 that the cartridge 300 may be positioned upon. Thebase 310 may form a flange extending outward from the wall 312. The wall312 may extend upward from the base 310, transverse to a direction thatthe base 310 extends in. The wall 312 may extend around and define acavity 314 that may receive components of the cartridge including thetranscutaneous analyte sensor 24 and the needle 302 among othercomponents disclosed herein. The wall 312 may extend around at least aportion of the needle cover 304. The wall 312 may extend upward to anupper opening 316 that exposes the components retained by the body 308.The wall 312 may including an inner surface configured to face inwardtowards a central portion of the cartridge 300 and the transcutaneousanalyte sensor 24 and an outer surface facing opposite the innersurface. The outer surface of the wall may be configured to bepositioned within at least a portion of an applicator. The outer surfaceof the wall may comprise a mating surface for a receiver of theapplicator, and may be contoured to a shape of an inner surface of thereceiver.

The wall 312 may be shaped similarly as the wall 146 discussed in regardto the cartridge 104 shown in FIG. 5. A protrusion 318 may be positionedon the outer surface of the cartridge 300 and may extend in an axialdirection. The protrusion 318 may be configured to align the cartridge300 with the receiver of the applicator.

The body 308 may include a retainer 320 that may operate and bestructured similarly as the retainer 152 discussed in regard to thecartridge 104.

Referring to FIG. 34, the body 308 of the cartridge 300 may include acentral cavity 322 that is configured to receive the needle 302 whenpositioned within the body 308 of the cartridge 300.

Referring back to FIG. 30, the cartridge 300 may include a removablecover 324 that extends over a portion of the body 308. The removablecover 324 covers the upper opening 316 and may block access to thecomponents contained within the body 308. The removable cover 324 maycover the contents of the cartridge 300, including the transcutaneousanalyte sensor 24 and the needle 302 within the cartridge 300. Theremovable cover 324 may comprise a flap that extends over the upperopening 316, and may have an adhesive that couples the cover 324 to thebody 308. The cover 324 may include a tab 326 for an individual to graspto peel the cover 324 from the body 308. The removable cover 324 may beconfigured to form a hermetic seal of the upper opening 316, in asimilar manner as the removable cover 154.

The components of the transcutaneous analyte sensor system may beretained by the body 308 in a similar manner as discussed in regard tothe cartridge 104, and the cartridge 300 may be utilized in a similarmanner as the cartridge 104.

FIG. 31 illustrates a perspective view of the needle 302 with the needlecover 304 extending over the length of the needle 302. The needle cover304 extends over the penetrating tip 306 of the needle 302.

The needle 302 may have a “C” shape with a fold of needle materialextending on two sides of a needle channel 328. The needle channel 328may be configured for the transcutaneous analyte sensor 24 to extend in,such that the needle 302 upon insertion into the skin may guide anddeposit the transcutaneous analyte sensor 24 within the individual'sskin. FIG. 34, for example, illustrates the transcutaneous analytesensor 24 positioned within the needle channel 328 prior to insertion ofthe needle 302. A needle hub 330 may be positioned at a proximal end ofthe needle shaft and may include coupling members 332 that may beconfigured to engage a releasable coupler. The coupling members 332 asshown in FIG. 31 may comprise cavities within the needle hub 330.

The needle cover 304 may comprise a sheath configured to extend over atleast a portion of the needle 302 and similarly may have a “C” shapewith a fold of needle cover material extending on two sides of a needlecover channel 334. The needle 302 may be positioned within the needlecover channel 334 and the “C” shape may expose the needle channel 328such that the transcutaneous analyte sensor 24 may be positioned withinthe needle channel 328. The needle cover 304 may include a needle coverhub 336 at a proximal end of the needle cover 304 and a contact surface338 at a distal end of the needle cover 304 for contacting a portion ofan individual's skin to retract the needle cover 304 relative to theneedle 302. The needle cover hub 336 may be configured to slide within achannel of the applicator.

FIG. 33 illustrates a perspective view of the cartridge 300 includingthe cover 324 in position on the cartridge body 308. Similar to thecartridge 104 shown in FIG. 5, the cartridge 300 may comprise a unitthat is coupled to an applicator for the transcutaneous analyte sensorcontained therein.

FIG. 34 illustrates a cross sectional view of the cartridge 300including the cover 324 in position on the cartridge body 308. Theneedle cover 304 is shown to extend over the needle 302, with thetranscutaneous analyte sensor 24 in position within the needle 302.

The cartridge 300 may be utilized with an applicator that is configuredsimilarly as the applicator 102 shown in FIG. 2. The applicator 102 maybe modified to accommodate the configuration of the needle 302 andneedle cover 304. For example as shown in FIG. 35, a releasable coupler340 may operate and be configured similarly as the releasable coupler218 shown in FIG. 9. The releasable coupler 340 however may be modifiedto include protrusions (similar to the protrusions 219 a, b shown inFIG. 9) that fit within the coupling members 332 (shown in FIG. 31) ofthe needle hub 330. Further, the carriage of the insertion actuator maybe configured to include a channel 342 (marked in FIG. 36) for theneedle cover hub 336 to slide along as the needle 302 is inserted intothe individual's skin.

FIG. 35 illustrates an embodiment of such an applicator in which thesteps of FIGS. 21 and 22 have been performed. The releasable coupler 340is coupled to the needle 302. Upon the step shown in FIG. 24 beingperformed, the needle 302 and the needle cover 304 may both be movedaxially downward by the insertion actuator (which may operate similarlyas with the applicator 102).

FIG. 36 illustrates the needle 302 and the needle cover 304 both beingmoved axially downward by the insertion actuator, with the needle 302being inserted into the skin of the individual. The contact surface 338of the needle cover 304 may contact the individual's skin yet be toodull to penetrate the skin. As such, the needle cover 304 may be slidaxially upward relative to the needle 302 as the needle 302 movesaxially downward into the individual's skin. The needle cover hub 336may include a releasable coupler 337 (marked in FIG. 32) that couples toa coupling member on the needle hub 330, yet the force against theindividual's skin may be strong enough to release the releasable coupler337. The force against the needle cover 304 may cause the needle cover304 to slide and uncover a portion of the needle 302 that is insertedinto the individual's skin. The needle cover 304 and particularly theneedle cover hub 336 may slide within the channel 342 of the insertionactuator.

Upon the retraction actuator operating (which may operate similarly asthe retraction actuator of the applicator 102), the needle 302 may beretracted out of the individual's skin and resheathed within the needlecover 304. Referring to FIG. 37, the needle 302 and the needle cover 304are both shown in a retracted position after the retraction actuator hasoperated. The needle 302 is coupled to the needle cover 304 by way ofthe releasable coupler 337. The release actuator (which may operatesimilarly as the release actuator of the applicator 102) may thenoperate to apply the pressing surface 339 to the releasable coupler 340shown in FIG. 35 and release the needle 302 from within the releasablecoupler 340. The pressing surface 339 may deflect the arms of thereleasable coupler 340 in a similar manner as the operation of therelease actuator of the applicator 102. The pressing surface 339 mayfurther press the needle (sheathed within the needle cover 304) axiallydownward out of the channel 342 of the insertion actuator and out of theapplicator housing. The force of the pressing surface 339 may besufficient to eject the sheathed needle 302.

The embodiment referenced in FIGS. 30-37 may beneficially keep theneedle 302 sheathed by the needle cover 304 prior to insertion of theneedle 302 into the individual's skin. As such, an individual may beblocked from access to the needle 302 and particularly the penetratingtip of the needle prior to insertion of the needle 302 into theindividual's skin. The needle cover 304 may then be resheathed over theneedle 302 at the time the needle 302 is released from the applicatorhousing and comprises a unit for discard. The needle cover 304 providesa similar purpose as the needle cover 132 shown in FIG. 3, namely toblock access to the needle 302 after use of the needle 302.

FIG. 38 illustrates an embodiment of an applicator 350 that isconfigured similarly as the applicator 102, yet includes an indicator352 indicating when the release actuator is to be operated. Theindicator 352 may comprise a visual indicator, which may comprise asurface, a color, or a combination thereof as shown in FIG. 38, or otherforms of visual indicators. As shown in FIG. 38, the indicator 352 maycomprise a surface of the release actuator that moves upward at a timethe release actuator is to be activated. The surface may be colored toprovide a greater visual impact to an individual. The indicator 352 maycomprise all or a portion of a control device 354 for the releaseactuator, which may operate similarly as the control device 178 shown inFIG. 22. The indicator 352 may be activated by the control device 356for the insertion actuator being pressed in a similar manner as shown inFIG. 24. The control device 354 may include a portion or activate amechanism or assembly that causes the indicator 352 to move upward, toindicate that the control device 354 may be pressed and the needle mustbe released from the applicator housing. The user may then press thecontrol device 354 to activate the release actuator.

Various other forms of indicators may be utilized in other embodiments,including but not limited to visual, auditory, tactile, or other formsof indicators. The indicator may be provided on a display screen or thelike and may be provided in an electronic format in certain embodiments.

FIG. 39 illustrates an embodiment in which an applicator 380 may beconfigured similarly as the applicator 102, yet has a rectangular orsquare outer shape of the applicator housing. Such a shape may improvegrip upon the applicator housing. Other shapes or configurations may beutilized such as triangular, pentagonal, oval, or other shapes asdesired.

FIG. 40 illustrates an embodiment of a cartridge 400 that may beconfigured similarly as the cartridge 104 shown in FIG. 5, for example,or similarly as the cartridge 300 shown in FIG. 30. The cartridge 400,for example, may include a body 402 having a base 404 and a wall 406.The base 404 may form a bottom of the cartridge 400 that the cartridge400 may be positioned upon. The base 404 may form a flange extendingoutward from the wall 406. The wall 406 may extend upward from the base404, transverse to a direction that the base 404 extends in. The wall406 may extend around and define a cavity 408 that may receivecomponents of the cartridge including the transcutaneous analyte sensorand the needle 410 (marked in FIG. 41).

Referring to FIG. 41, the needle 410 may include a needle hub 412 at aproximal end of the needle 410. The needle hub 412 may couple to aproximal end 413 of a needle cover 414, with the needle cover 414configured to expand and contract axially along the length of the needle410. The distal end 415 of the needle cover 414 may be configured toslide along the shaft of the needle 410. The needle cover 414, forexample, may comprise an accordion structure that allows for expansionand contraction.

In a configuration in which the needle 410 is held in the cartridge 400prior to insertion of the needle 410, the needle cover 414 may be in thecompressed state as shown in FIG. 41. Thus, the shaft of the needle 410may be positioned for insertion into the individual's skin. When theneedle 410 is withdrawn from the individual's skin, the needle cover 414may expand axially along the shaft of the needle 410 to cover the needleshaft. FIG. 42, for example, illustrates such a configuration.

The retraction of the needle 410 may occur by any method disclosedherein. For example, a releasable coupler may engage the needle hub 412and retract the needle hub 412 according to embodiments herein. Theneedle cover 414 may extend over the retracted needle upon retraction ofthe needle 410.

FIGS. 43-51 illustrate an embodiment of a variation of a system 500 forinserting a transcutaneous analyte sensor into an individual's skin,including an applicator 502 and a cartridge 504. FIG. 43 illustrates across sectional view of the applicator 502 and the cartridge 504.Referring first to the cartridge 504, the cartridge 504 may beconfigured similarly as the cartridge 300 shown in FIG. 30, yet mayinclude a needle cover 507 that is configured to rotate relative to theneedle 508 to extend over at least a portion of the needle 508. Theneedle cover 507 may be configured to cover at least a portion of theneedle 508 following the needle 508 guiding the transcutaneous analytesensor into the skin of the individual. The needle 508 may be configuredto be moved relative to the needle cover 507 to be positioned into theneedle cover 507. The needle cover 507 as shown in FIG. 43 includes anarm 510 coupled to a sheath 512. The arm 510 couples to a pivot 514 thatcouples to a needle hub 516 positioned at a proximal end of the needleshaft. The pivot 514 allows the arm 510 to rotate to position the sheath512 over the penetrating tip 518 of the needle 508 at the desired time.The sheath 512 may be configured to extend over at least a portion ofthe needle 508. The needle cover 507 may be coupled to the wearablehousing 108 and configured to be separable from the wearable housing108.

As shown in FIG. 43, the arm 510 may rest upon a surface of the wearablehousing 108, and then as the needle 508 is retracted from the wearablehousing 108, the arm 510 may swing downward towards the penetrating tip518 to cover the tip 518 in a manner shown in FIG. 51.

The cartridge 504 may include a body 520 having a base 522 and a wall524. The base 522 may form a bottom of the cartridge 504 that thecartridge 504 may be positioned upon. The base 522 may form a flangeextending outward from the wall 524. The wall 524 may extend upward fromthe base 522, transverse to a direction that the base 522 extends in.The wall 524 may extend around and define a cavity 526 that may receivecomponents of the cartridge including the transcutaneous analyte sensor24 and the needle 508. The wall 524 may extend around at least a portionof the needle cover 507. The wall 524 may extend upward to an upperopening 528 that exposes the components retained by the body 520. Thewall 524 may including an inner surface configured to face inwardtowards a central portion of the cartridge 504 and the transcutaneousanalyte sensor 24 and an outer surface facing opposite the innersurface. The outer surface of the wall may be configured to bepositioned within at least a portion of an applicator. The outer surfaceof the wall may comprise a mating surface for a receiver of theapplicator, and may be contoured to a shape of an inner surface of thereceiver.

The wall 524 may be shaped similarly as the wall 146 discussed in regardto the cartridge 104 shown in FIG. 5. The body 520 may include aretainer 530 that may operate and be structured similarly as theretainer 152 discussed in regard to the cartridge 104.

Referring to FIG. 43, the body 520 of the cartridge 504 may include acentral cavity 531 that is configured to receive the needle 508 whenpositioned within the body 520 of the cartridge 504. The cartridge 504may include a removable cover that operates similarly as the cover 324shown in FIG. 30. The components of the transcutaneous analyte sensorsystem may be retained by the body 520 in a similar manner as discussedin regard to the cartridge 104, and the cartridge 504 may be utilized ina similar manner as the cartridge 104.

The applicator 502 comprises a transcutaneous analyte sensor applicator,and is configured to apply other components of the transcutaneousanalyte sensor system to the skin of an individual including thewearable housing 108 and patch 106 of the transcutaneous analyte sensorsystem. The applicator may deploy all or a portion of components of anon-skin sensor assembly 12 to an individual's skin.

The applicator 502 comprises a reusable applicator, and may providereusable functionality in a similar manner as the applicator 102.

FIG. 43 illustrates components of the applicator 502. The applicator 502may include an applicator housing 532, which may comprise a singlecomponent or multiple components, similar to the housing of theapplicator 102. The applicator housing may have a cylindrical shape withan outer surface configured to be gripped by an individual. Theapplicator housing 532 may be configured to be gripped to apply thetranscutaneous analyte sensor into the individual's skin. Other shapesof the applicator housing 532 may be utilized as desired.

The applicator housing 532 may include a top portion (formed by thecontrol device 540) and a bottom portion including an opening 588 forthe transcutaneous analyte sensor to be deployed from to be insertedinto the individual's skin. A side portion may be positioned between thetop portion and the bottom portion. The opening 588 may be configuredfor the needle 508 and the transcutaneous analyte sensor 24 to passthrough to insert the transcutaneous analyte sensor 24 into theindividual's skin.

FIG. 43 illustrates other components of the applicator 502. Thecomponents may include an actuator that may be coupled to the applicatorhousing 532 and that is configured to insert the needle 508 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. Such an actuator may be referred to as aninsertion actuator. The insertion actuator may include components thatmay include a control device 534 and a driver 536 (marked in FIG. 49),and may include a carriage 538. The insertion actuator may include othercomponents (or fewer components) in other embodiments. The applicator502 may include a release actuator that is configured to release theneedle 508 from within a releasable coupler. The release actuator mayinclude components that may include a control device 540 and may includea pressing surface 543 (marked in FIG. 48) that is configured to apply aforce to the releasable coupler to cause the needle 508 to release fromthe releasable coupler. The release actuator may be configured torelease the needle 508 from the releasable coupler to allow the needle508 to be passed through the opening 588 at the bottom portion of theapplicator housing. The release actuator may include other components(or fewer components) in other embodiments. The applicator 502 mayinclude a retraction actuator that is configured to retract the needle508 from the individual's skin following insertion of the transcutaneousanalyte sensor into the individual's skin. The retraction actuator mayinclude components that may include a driver 542 and a carriage 544. Theretraction actuator may include other components (or fewer components)in other embodiments. The configuration of components in the applicator502 may be varied in other embodiments.

FIG. 44 illustrates a perspective view of the carriage 538 of theinsertion actuator. The carriage 538 may comprise a body configured toslide within an interior cavity of the applicator 502 that may bedefined by the applicator housing 532. The carriage 538 may beconfigured to slide relative to the applicator housing and be configuredto be slid by the driver 536. The carriage 538 may include an outer ring546. The outer ring 546 may surround a cavity 548 of the carriage 538.The cavity 548 may be configured to receive the carriage 544 of theretraction actuator and may be configured to receive a driver 542(marked in FIG. 43) of the retraction actuator. The driver 542 may beconfigured to drive the needle 508 out of the individual's skin.

The carriage 538 may include a central body 550 that spans the interiorof the outer ring 546 of the carriage 538. The outer ring 546 mayinclude a channel 552 (marked in FIG. 45) configured to receive the wall524 of the cartridge 504.

An upper surface of the carriage 538 may include a releasable coupler554 a, b configured to couple to a coupling member 556 of the insertionactuator as shown in FIG. 47 (a similar coupling member 556 is on theopposite side of the control device 534). The releasable coupler 554 a,b may comprise arms having openings configured for the coupling member556 of the insertion actuator to engage. The coupling member 556 maycomprise protrusions that enter into the openings of the releasablecoupler 554 a, b. In other embodiments, the releasable coupler 554 mayhave different forms.

FIG. 44 illustrates a central channel 557 may be provided (excluded fromview in FIGS. 43, 50, and 51). The central channel 557 may be configuredfor the needle 508 to be retracted into upon operation of the retractionactuator and may provide a guide path for a column 558 (marked in FIG.48) of the retraction actuator to extend in.

FIG. 45 illustrates a perspective view of a lower surface of thecarriage 538. The lower surface of the carriage may include a receiver560 that is configured to receive at least a portion of thetranscutaneous analyte sensor system. The receiver 560 may comprise acavity that is configured to receive the transcutaneous analyte sensorsystem. The receiver 560 may include at least one releasable coupler 562a, b that is configured to couple to the wearable housing 108 of thetranscutaneous analyte sensor system. The releasable coupler 562 a, bmay comprise a protrusion configured to enter into a cavity 123 (markedin FIG. 3) of the wearable housing 108 to couple to the wearable housing108. In other embodiments, other forms of releasable couplers 562 a, bmay be utilized.

An opening 565 may be positioned on the carriage 538 and may extendthrough the lower surface of the central body 550 to the upper surfaceof the central body 550. The opening 565 may be configured for theneedle 508 to pass through.

The carriage 538 may include openings 564 a, b configured for releasablecouplers of the carriage 544 of the retraction actuator to extendthrough, to couple the carriages 538, 544 together.

FIG. 46 illustrates a bottom perspective view of the carriage 544 of therelease actuator. The carriage 544 may be configured to slide relativeto the applicator housing and be configured to be slid by the drivers542 and 536. The carriage may include a releasable coupler 566 that isconfigured to releasably couple to the needle 508. The releasablecoupler 566 may include protrusions 568 a, b that are configured toengage coupling members of the needle hub 516 to releasably couple tothe needle 508. The protrusions 568 a, b may be movable upon a pressingsurface pressing upon arms 570 a, b coupled to the protrusions 568 a, b.The releasable coupler 566 may be configured to retain the needle 508 atleast partially within the applicator housing 532 following insertion ofthe transcutaneous analyte sensor 24 into the individual's skin andremoval of the applicator housing 532 from the transcutaneous analytesensor 24, and configured to release the needle 508 from within theapplicator housing 532 following insertion of the transcutaneous analytesensor 24 into the individual's skin.

The carriage 544 of the retraction actuator may include deflectable arms572 a, b having releasable couplers 574 a, b at their ends for couplingto the openings 564 a, b of the carriage 538 of the insertion actuatorshown in FIG. 45. The releasable couplers 574 a, b may be configured torelease from the openings 564 a, b of the carriage 538 upon contact withcoupler releases in the form of deflectors 576 of the applicatorhousing, with one such deflector being shown in FIG. 50 along an innersidewall of the applicator housing.

The configuration of the carriage 544 may be varied in otherembodiments.

FIG. 47 illustrates a perspective view of the control device 534 of theinsertion actuator. The control device 534 may comprise a button thatmay be pressed or other device that may be moved to activate theinsertion actuator. The control device 534 may be configured to be slidlaterally to activate the insertion actuator. The control device 534 mayinclude a button surface 578 and a control arm 580 that extends from thebutton surface 578. The control arm 580 may include a coupling member556 in the form of a protrusion extending laterally outward from thecontrol arm 580. A similar coupling member 556 is on the opposite sideof the control device 534. The control arm 580 may further comprise areleasable coupler in the form of a lock 582 at a portion of the controlarm 580 distal the button surface 578, configured to lock the controldevice 534 in position. The lock 582 may comprise a deflectable hookstructure as shown in FIG. 47.

FIG. 48 illustrates a bottom perspective view of the release actuator,showing the control device 540 and the pressing surface 543. The controldevice 540 may comprise a button that may be pressed by an individual toactivate the release actuator. The control device 540 may be coupled tothe pressing surface 543, which may be configured to press against thereleasable coupler 566 to release the needle 508 from within theapplicator housing 532. The pressing surface 543 as shown in FIG. 48 maycomprise a distal surface of a column 558 that extends axially from thecontrol device 540. The column 558 may include outward extending ridgescomprising the pressing surface 543.

The release actuator may further include a lock release 584, which maycomprise a surface configured to release the lock 582 of the controldevice 534 from a locking surface of the applicator housing.

FIG. 49 illustrates a perspective assembly view of the carriage 538 ofthe insertion actuator with the carriage 544 of the release actuatorpositioned over the carriage 538. The driver 542 of the retractionactuator is positioned between the carriages 538, 544 for compression bythe carriages 538, 544. The driver 536 of the insertion actuator may bepositioned upon the carriage 538 of the insertion actuator andconfigured to be compressed between the carriage 538 and a portion ofthe applicator housing 532. The control device 534 may be positionedabove the carriage 544 with the central channel 557 extending through anopening in the control arm 580 of the control device 534.

FIG. 50 illustrates a perspective cross sectional view of the applicator502 showing that the applicator housing 532 includes a receiver 586 forreceiving the cartridge 504. The receiver 586 may be configured for thecartridge 504 retaining the transcutaneous analyte sensor to be insertedinto. The receiver 586 may comprise a cavity within the applicatorhousing 532 that receives the cartridge 504. The cartridge 504 may beinserted into the receiver 586 axially through an opening 588 at abottom of the applicator housing 532.

The applicator 502 may operate in a manner shown in FIGS. 43, 50 and 51.FIG. 43 illustrates the applicator 502 in an initial state, in which theapplicator 502 is configured to receive the cartridge 504 and componentsof the transcutaneous analyte sensor system including the transcutaneousanalyte sensor 24, the wearable housing 108, and the patch 106. Theelectronics unit 26 is shown to be coupled to the wearable housing 108upon insertion into the receiver 586 of the applicator 502, however theelectronics unit 26 may be excluded and later coupled to the wearablehousing 108 as desired.

The applicator 502 in the initial state has the carriage 538 of theinsertion actuator in a lowered state, proximate the lower opening 588of the applicator 502. The carriage 538 of the insertion actuator may bepressed to the lowered state by the force provided by the driver 536 ofthe insertion actuator. The driver 536 may be configured to drive theneedle 508 into the individual's skin to insert the transcutaneousanalyte sensor into the individual's skin. The carriage 544 of theretraction actuator may be in a raised state, pressed to the raisedstate by the force of the driver 542 of the retraction actuator. Thereleasable couplers 574 a, b shown in FIG. 46 are not yet coupling thecarriages 538, 544 together.

The cartridge 504 may be inserted into the receiver 586 of theapplicator housing 532 to allow the releasable coupler 562 a, b of thecarriage 538 of the insertion actuator to engage the wearable housing108 of the on-skin sensor assembly. A removable cover of the cartridge504 may previously have been removed by an individual.

FIG. 50 illustrates after the cartridge 504 has been fully inserted intothe receiver 586 of the applicator housing 532. The cartridge 504 may beinserted in the axial dimension of the applicator housing 532, which isthe same dimension that the transcutaneous analyte sensor 24 as well asother components of the transcutaneous analyte sensor system will bedeployed from the applicator housing 532 (although in an opposite axialdirection that the cartridge 504 is inserted into the receiver 586). Theinsertion of the cartridge 504 and the transcutaneous analyte sensor 24into the receiver 586 of the applicator housing 532 may compress andthus provide energy to both the driver 536 of the insertion actuator(shown in FIG. 49 and not shown in FIG. 50) and the driver 542 of theretraction actuator. Both drivers 536, 542 are compressed in theconfiguration shown in FIG. 50. In an embodiment in which the drivers536, 542 are springs, the springs may be compressed by the insertion ofthe cartridge 504 and the transcutaneous analyte sensor 24 into thereceiver. The cartridge 504 may include a pressing surface upon an uppersurface of the cartridge 504 to press against the carriage of theinsertion actuator to provide energy to the insertion actuator.

The insertion of the cartridge 504 fully into the receiver 586 of theapplicator housing 532 also causes the releasable coupler 554 a, b(marked in FIG. 44) of the insertion actuator to engage the couplingmember 556 (marked in FIG. 47) of the control device 534. The engagementof the releasable coupler 554 a, b holds the carriage 538 of theinsertion actuator in position and prevents the driver 536 from pressingthe carriage 538 in an axial direction towards the lower opening 588 ofthe applicator housing 532. The releasable couplers 574 a, b shown inFIG. 46 engage the openings 564 a, b of the carriage 538 of theinsertion actuator shown in FIG. 45 to couple the carriages 538, 544.

As shown in FIG. 50, the wearable housing 108 of the transcutaneousanalyte sensor system may be positioned in the receiver 586 of the lowersurface of the carriage 538. The releasable coupler 562 a, b shown inFIG. 45 may couple to the cavity 123 shown in FIG. 3 to grip thewearable housing 108 to the lower surface of the carriage. Thus, as thecartridge 504 is withdrawn from the applicator housing 532, the wearablehousing 108 remains coupled to the receiver 560.

The releasable coupler 566 couples to the needle 508, particularly withthe protrusions 568 a, b of the releasable coupler 566 engaging couplingmembers of the needle hub 516. The needle 508 is shown to extenddownward from the wearable housing 108 of the transcutaneous analytesensor system, extending for insertion of the penetrating tip of theneedle 508 into the individual's skin.

With the cartridge 504 withdrawn from the applicator housing 532 asshown in FIG. 50, the transcutaneous analyte sensor system is inposition for application to the individual's skin by the applicator 502.The transcutaneous analyte sensor system may be moved axially downwardwithin the receiver 586 of the applicator housing 532 to contact theindividual's skin and be applied to the individual's skin.

The insertion actuator may operate to insert the needle 508 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. The control device 534 of the insertion actuatormay be pressed in a lateral direction, or a direction transverse to theaxial dimension of the applicator housing 532. The movement of thecontrol device 534 may compress a biasing spring 590 that is configuredto apply a biasing force to the control device 534. The movement of thecontrol device 534 may disengage the coupling member 556 shown in FIG.47 from the releasable coupler 554 a, b, by moving the coupling member556 laterally out of the openings of the releasable coupler 554 a, b.The force of the driver 536 shown in FIG. 49 upon the carriage 538causes the coupled carriages 544, 538 to descend rapidly with sufficientforce to drive the needle 508 into the individual's skin.

Further as shown in FIG. 51, upon the control device 534 of theinsertion actuator being pressed in a lateral direction, the lock 582shown in FIG. 47 may engage a locking surface of the applicator housing532. The lock 582 may prevent the control device 534 from undesirablymoving after the control device 534 has been pressed.

After the control device 534 has been pressed and the insertion actuatorhas been activated, the movement of the carriage 538 has inserted theneedle 508 into the individual's skin and has inserted thetranscutaneous analyte sensor 24 into the individual's skin. Further,the movement of the carriage 538 has pressed the patch 106 to theindividual's skin, allowing the patch 106 to adhere to the individual'sskin and providing an adhesive force to the skin for the transcutaneousanalyte sensor system.

Further, with the carriages 544, 538 both being slid downward within theapplicator housing 532, the releasable couplers 574 a, b may contact thecoupler release in the form of deflectors 576 shown in FIG. 50. Suchcontact may apply a force to the releasable couplers 574 a, b in lateraldirections that causes the releasable couplers 574 a, b to disengagefrom the openings 564 a, b. Accordingly, the carriages 538, 544 may bedecoupled from each other and able to slide relative to each other. Thereleasable couplers 574 a, b may be configured to automatically releaseupon contact with the coupler release in the form of the deflectors 576shown in FIG. 50. The retraction actuator accordingly may be configuredto automatically operate upon the needle 508 guiding the transcutaneousanalyte sensor into the individual's skin.

Referring to FIG. 51, with the carriages 538, 544 decoupled from eachother, the driver 542 of the retraction actuator may apply an upwardforce to the carriage 544 of the retraction actuator to move thecarriage 544 upward.

The upward movement of the retraction actuator carriage 544 may causethe needle 508 that is coupled to the releasable coupler 566 (shown inFIG. 46) to retract out of the individual's skin, due to the upwardmovement of the releasable coupler 566. The releasable coupler 566 maycause the needle 508 to slide upwards, with the arm 510 of the needlecover 507 (marked in FIG. 43) contacting the opening 565 shown in FIG.45, to cause the arm 510 to pivot and rotate towards the needle 508. Thesheath 512 of the needle cover 507 extends over the penetrating tip ofthe needle 508 as shown in FIG. 51. The needle cover 507 accordingly mayextend over at least a portion of the needle 508. The retractionactuator may position the needle 508 into the needle cover 507.

The releasable coupler 566 retains the needle 508 to the applicatorhousing 532 following insertion of the transcutaneous analyte sensor 24into the individual's skin and removal from the applicator housing fromthe transcutaneous analyte sensor 24. The transcutaneous analyte sensor24 remains within the individual's skin as the applicator housing isremoved from the transcutaneous analyte sensor 24.

With the applicator housing removed from the transcutaneous analytesensor 24, the release actuator may be operated to release the needle508 from the releasable coupler 566.

The control device 540 of the release actuator may be pressed axiallydownward, causing the column 558 of the release actuator to similarlymove axially downward. The pressing surface 543 (marked in FIG. 48) ofthe release actuator accordingly may be moved axially downward to pressagainst the releasable coupler 566 shown in FIG. 46 and particularlypress against the deflectable arms 570 a, b shown in FIG. 46. Thepressure of the pressing surface 543 against the deflectable arms 570 a,b causes the protrusions 568 a, b (marked in FIG. 46) to release fromthe coupling members of the needle hub 516. Accordingly, the releasablecoupler 566 may be released from the needle 508. The needle 508 andneedle cover 507 may be released from the applicator housing 532 withthe needle cover 507 covering the penetrating tip of the needle 508.

The release actuator may be configured to release the needle 508 coveredby the needle cover 507 from within the applicator housing 532 followinginsertion of the needle 508 into the individual's skin. The releasablecoupler 566 configured to retain the needle 508 is configured to releasethe needle 508 positioned within the needle cover 507 from theapplicator housing. The force of the column 558 of the release actuatormay eject the needle 508 and the needle cover 507 together as a unitfrom the applicator housing 532 for discard (i.e., release from theapplicator housing with velocity).

Further, lock release 584 (marked in FIG. 48) may contact the lock 582of the control device 534, to press the lock 582 under a locking surfaceof the applicator housing. As such, the control device 534 may be freeto move in the opposite lateral direction than shown in FIG. 51 and maybe moved back to the position shown in FIG. 50 due to the force appliedby the biasing spring 590.

The needle 508 may be released from the applicator housing 532 fordiscard, as the needle 508 may have been contaminated through theprocess of insertion within the individual's skin. The needle 508accordingly may be a single use needle that is configured to discardwithin a sharps container or other disposal area. The needle 508 mayremain sheathed within the needle cover 507 such that an individual doesnot contact the used needle 508 and be subject to the contamination ofthe needle 508 or otherwise be injured by the penetrating tip of theneedle 508. The needle 508 may remain locked in position within theneedle cover 507 such that an individual cannot access the contaminatedportion of the needle 508. The needle 508 and needle cover 507 togethermay form a unit for disposal following insertion into an individual'sskin and separation from the applicator housing.

Upon release of the needle 508 and needle cover 507 from the applicatorhousing 532, and following the return of the control device 534 to theposition shown in FIG. 43, the applicator is in a configuration fordeployment of another transcutaneous analyte sensor 24 and othercomponents of a transcutaneous analyte sensor system. As such, theapplicator 502 is configured for multiple uses, and is not intended tobe discarded. The applicator 502 returns to a configuration shown inFIG. 43 for repeat of the steps shown in FIGS. 50 and 51. The applicator502 may be loaded with another cartridge 504 and the steps disclosedherein may repeat as desired.

FIG. 52 illustrates an embodiment of a cartridge 600 that may beutilized with an applicator 602 (marked in FIG. 53) that may beconfigured similarly as the applicator 502 shown in FIGS. 43-51. Thecartridge 600, however, may be configured to remove a used needle fromthe applicator 602 through use of a needle coupler 604 that isconfigured to engage a used needle that is coupled to the applicatorhousing and retain the used needle when the body 606 of the applicatoris withdrawn from the applicator housing 608.

The cartridge 600 may include a lower surface 610 and an upper surface612 (marked in FIG. 53) that faces opposite the lower surface 610. Thelower surface 610 accordingly faces opposite the upper surface 612.Referring to FIG. 53, the cartridge 600 may include a retainer 618 thatis configured to retain a transcutaneous analyte sensor to the body 606,and may include a receiver 620 that is configured to receive an unusedneedle 621 that is coupled to the transcutaneous analyte sensor. Thus,in embodiments, the needle coupler 604 may be positioned on an oppositeside of the cartridge 600 (lower surface 610) from the retainer 618(upper surface 612), the transcutaneous analyte sensor, unused needle621, and the housing for the transcutaneous analyte sensor. Thetranscutaneous analyte sensor may be coupled to the retainer 618 and theunused needle 621 may be positioned within the receiver 620 and coupledto the transcutaneous analyte sensor.

Referring to FIG. 53, the applicator 602 may be configured similarly asthe applicator 502 shown in FIGS. 43-51, and may include an insertionactuator (including carriage 624, driver 626, and control device 628), aretraction actuator (including carriage 630, driver 632) and areleasable coupler 634 for a needle. The insertion actuator andretraction actuator may operate in a similar manner as the respectiveactuators discussed in regard to the applicator 502 shown in FIGS.43-51. The needle coupler 604 of the cartridge 600, however, may beutilized to remove the used needle 636 from the applicator 602. Theneedle 636 may be used because it has already been inserted into theskin of an individual.

The body 606 of the cartridge 600 may be configured to couple to theapplicator housing 608 and may include a wall 616 that extends around atleast a portion of the transcutaneous analyte sensor. The body 606 maybe configured to be inserted into a receiver 622 of the applicator 602with the upper surface 612 facing towards the applicator housing 608 andalternatively with the lower surface 610 facing towards the applicatorhousing 608.

Thus, as the cartridge 600 is inserted into the receiver 622 and coupledto the applicator housing 602 with the needle coupler 604 and lowersurface 610 facing the used needle 636, the needle coupler 604 mayengage the used needle 636. FIG. 54, for example, illustrates suchengagement. The cartridge 600 may then be withdrawn from the applicatorhousing 602, with the used needle 636 being carried with the cartridge600 away from the applicator housing 602. As such, the used needle 636is coupled to the needle coupler 604 and away from the releasablecoupler 634. The used needle 636 may be retained to the cartridge 600with the needle coupler 604 when the cartridge 600 is withdrawn from theapplicator housing 602. The used needle 636 may remain coupled to thecartridge 600 for a time that the cartridge 600 is eventually discarded,to keep the used needle 636 separate and sheathed within the body 606 ofthe cartridge 600.

With the cartridge 600 removed from the applicator housing 602, thecartridge 600 may be rotated so that the upper surface 612 faces theapplicator housing 602. For example, a cover 638 or lid as marked inFIG. 53 may be removed to expose the wearable within the cartridge 600.The cartridge 600 may be inserted into the receiver 622 of theapplicator housing 602 with the upper surface 612 facing the applicatorhousing 602 to couple the unused needle 621 to the releasable coupler634. Upon the unused needle 621 being inserted into the individual'sskin, the process may be repeated to remove such needle 621 from theapplicator housing 602.

Variations in the process of removing a needle with a cartridge, andother processes, may be provided. FIGS. 55-59, for example, illustratean embodiment in which the cartridge 700 may include a needle coupler702 that is positioned on the same upper surface 704 or upper side ofthe cartridge 700 (as opposed to the lower surface or side) as theretainer, the wearable housing, unused needle 706, the transcutaneousanalyte sensor, and the electronics unit 26. The needle coupler 702 maybe configured to engage a used needle that is coupled to the applicatorhousing and retain the used needle when the body is withdrawn from theapplicator housing. The cartridge 700 otherwise may be configuredsimilarly as the cartridge 104 shown in FIG. 5, for example, orsimilarly as the cartridge 300 shown in FIG. 30. For example, thecartridge 700 may include a body 708 configured to be coupled to anapplicator housing, a retainer 710 configured to retain a transcutaneousanalyte sensor to the body 708, a receiver 712 marked in FIG. 56configured to receive the unused needle 706 that is coupled to thetranscutaneous analyte sensor. The body 708 may include a wall 711extending around at least a portion of the transcutaneous analytesensor.

The cartridge 700 may be utilized in combination with an applicator 714(marked in FIG. 56). The applicator 714 may be configured similarly asthe applicators 502, 602, yet may include a needle carriage 716 that maybe configured to retain a needle after insertion into the individual'sskin. The applicator 714 may include an applicator housing 718 that maybe configured to be gripped to apply the transcutaneous analyte sensorinto the individual's skin and may include an opening 720 (marked inFIG. 59) at a bottom surface 722 (marked in FIG. 59) of the applicatorhousing 718 for the transcutaneous analyte sensor to be deployed from.The applicator 714 may include a driver 724 for inserting a needle 726into an individual's skin to guide the transcutaneous analyte sensorinto the individual's skin. The driver 724, for example, may drive acarriage 728 that is coupled to the needle carriage 716, and drives boththe wearable housing, the needle 726, and the needle carriage 716downward towards the individual's skin to insert the needle 726 into theindividual's skin.

The needle carriage 716 may comprise a portion of a retraction actuator,including a driver 730 that drives the needle carriage 716 upward withrespect to the carriage 728 to retract the needle 726 followinginsertion into the individual's skin. The needle carriage 716 may beconfigured to rotate about an axis that is vertical with respect to theopening 720. The rotation of the needle carriage 716 may reposition theused needle to be aligned with and engaged with the needle coupler 702when a subsequent cartridge is inserted into the applicator housing 718.

FIG. 56, for example, illustrates a cross sectional view of thecartridge 700 inserted into the receiver of the applicator housing 718.The insertion may provide energy to the drivers 724, 730. The needlecarriage 716 may include two releasable couplers 732, 734 that rotateabout an axis of a central shaft 736, as marked in FIG. 57. The centralshaft 736 of the needle carriage 716 may include a gear, with gear teeth738 that engage a gear, with gear teeth 740 that is coupled to thecontrol device 742. The gear of the control device 742 may be configuredto rotate the needle carriage 716 about the axis of the central shaft736 that is vertical with respect to the opening 720. As such, movementof the control device 742 causes rotation of the needle carriage 716 dueto engagement of the gears.

In embodiments, the gear teeth 740 may be angled such that pressing thecontrol device 742 does not rotate the central shaft 736, and retractionof the control device 742 due to the driver 744 (shown in FIG. 56)causes the central shaft 736 to rotate. As such, the gears may operateas a one-way gear for causing the needle carriage 716 to rotate onlyupon release of the control device 742 following insertion of the needleinto the individual's skin.

The rotation of the used needle may position the used needle to engagethe needle coupler 702 of the cartridge 700, to withdraw the used needlefrom the needle carriage 716.

FIGS. 56-59, for example, illustrate a method of operation of theapplicator 714 and cartridge. In FIG. 56, the cartridge 700 may beinserted to the receiver of the applicator housing 718 to couple thecartridge 700 to the applicator housing 718. The used needle 743 may beengaged with the needle coupler 702 upon insertion of the cartridge 700.Further, the unused needle 726 may be engaged with the releasablecoupler 732. The cartridge 700 may then be withdrawn from the applicatorhousing 718 to retain the used needle 743 to the cartridge 700 with theneedle coupler 702.

The control device 742 may be pressed to cause the needle carriage 716and the carriage 728 to move towards the individual's skin. The needlecarriage 716 may retract according to methods disclosed herein towithdraw the needle 726 from the individual's skin. The resultingposition of the needle carriage 716 is shown in FIG. 57.

The control device 742 may then be released, to cause the gear to engagethe central shaft 736 and rotate the needle 726 about the axis of theshaft 736 and to align with the needle coupler 702. The needle carriage716 may be rotated within the applicator housing to position the usedneedle 726 for alignment with the needle coupler 702. FIGS. 58 and 59,for example, illustrate the position of the needle 726.

A next cartridge, configured similarly as cartridge 700, may then beinserted into the receiver of the applicator housing 718 to engage theneedle coupler 702 with the used needle 726.

The processes and structures disclosed herein may be varied inembodiments.

FIG. 60 illustrates an embodiment of a cartridge 800 that may beconfigured similarly as the cartridge 300 shown in FIG. 30, yet mayinclude a needle cover 802 also serving as a needle hub that isconfigured to rotate relative to the needle 804 to extend over at leasta portion of the needle 804. The cartridge 800 may be utilized in asystem for inserting a transcutaneous analyte sensor into anindividual's skin. The needle cover 802 as shown in FIG. 60 includes twosheath bodies 806 a, b that couple together to form a sheath configuredto extend over at least a portion of the needle 804. The needle 804 maybe configured to be moved relative to the needle cover 802 to bepositioned into the needle cover 802. The needle cover 802 is configuredto cover at least a portion of the needle 804 following the needle 804inserting the transcutaneous analyte sensor into the skin of theindividual. The needle cover 802 may include a releasable coupler 808that is configured to couple to a coupling member of the wearablehousing 108. The releasable coupler 808 may comprise a latch thatextends into a coupling member in the form of a cavity in the wearablehousing 108. The releasable coupler 808 may be positioned at an end ofthe needle cover 802 that covers the penetrating tip of the needle 804when the needle cover 802 covers the needle 804. An opposite end of theneedle cover 802 may include a pivot 810 (marked in FIG. 61) that theneedle 804 is configured to pivot about, to rotate into a cavity of theneedle cover 802. The needle cover 802 may be coupled to the wearablehousing 108 and configured to be separable from the wearable housing108.

Referring to FIG. 61, the two sheath bodies 806 a, b may enclose acavity 812 that the needle 804 may be rotated into upon release from thewearable housing 108. The two sheath bodies 806 a, b may be separatedfrom each other to define an opening 814 that the needle 804 may passthrough to enter the cavity 812. A spring 816 may be provided in theneedle cover 802 that applies a force to bias the needle 804 towards thecavity 812. The needle 804 may couple to the pivot 810 at a proximal endof the needle 804 opposite the penetrating tip of the needle 804.

Referring back to FIG. 60, the cartridge 800 may include a body 818having a base 820 and a wall 822. The base 820 may form a bottom of thecartridge 800 that the cartridge 800 may be positioned upon. The base820 may form a flange extending outward from the wall 822. The wall 822may extend upward from the base 820, transverse to a direction that thebase 820 extends in. The wall 822 may extend around and define a cavity824 that may receive components of the cartridge including thetranscutaneous analyte sensor 24 and the needle 804. The wall 822 mayextend around at least a portion of the needle cover 802. The wall 822may extend upward to an upper opening 826 that exposes the componentsretained by the body 818. The wall 822 may including an inner surfaceconfigured to face inward towards a central portion of the cartridge 800and the transcutaneous analyte sensor 24 and an outer surface facingopposite the inner surface. The outer surface of the wall may beconfigured to be positioned within at least a portion of an applicator.The outer surface of the wall may comprise a mating surface for areceiver of the applicator, and may be contoured to a shape of an innersurface of the receiver.

The wall 822 may be shaped similarly as the wall 146 discussed in regardto the cartridge 104 shown in FIG. 5. The body 818 may include aretainer 828 (marked in FIG. 61) that may operate and be structuredsimilarly as the retainer 152 discussed in regard to the cartridge 104.

Referring to FIG. 61, the body 818 of the cartridge 800 may include acentral cavity 831 that is configured to receive the needle 804 whenpositioned within the body 818 of the cartridge 800. Referring back toFIG. 60, the cartridge 800 may include a removable cover 830 thatoperates similarly as the cover 324 shown in FIG. 30. The components ofthe transcutaneous analyte sensor system may be retained by the body 818in a similar manner as discussed in regard to the cartridge 104, and thecartridge 800 may be utilized in a similar manner as the cartridge 104.

The cartridge 800 may be utilized with an applicator 832 as shown in anexploded view in FIG. 62. The applicator 832 comprises a transcutaneousanalyte sensor applicator, and is configured to apply other componentsof the transcutaneous analyte sensor system to the skin of an individualincluding the wearable housing 108 and patch 106 of the transcutaneousanalyte sensor system. The applicator may deploy all or a portion ofcomponents of an on-skin sensor assembly 12 to an individual's skin.

The applicator 832 comprises a reusable applicator, and may providereusable functionality in a similar manner as the applicator 102.

FIG. 62 illustrates components of the applicator 832. The applicator 832may include an applicator housing 834, which may comprise a singlecomponent or multiple components. As shown in FIG. 62, the applicatorhousing 834 may include a side cover body 839, a lower body 837, and anupper cap 841. The components of the applicator housing 834 may becoupled together to form a single applicator housing 834. The applicatorhousing 834 may be configured to be gripped by an individual to applythe transcutaneous analyte sensor into the individual's skin, to be heldduring deployment of the transcutaneous analyte sensor, as well as othercomponents of a transcutaneous analyte sensor system. The applicatorhousing 834 may have a cylindrical shape with an outer surfaceconfigured to be gripped by an individual. Other shapes of theapplicator housing 834 may be utilized as desired.

The applicator housing 834 may include a side portion (formed by theside cover body 839), a top portion (formed by the upper cap 841) and abottom portion including an opening 881 shown in FIG. 67 for thetranscutaneous analyte sensor to be deployed from to be inserted intothe individual's skin. The opening 881 may be configured for the needle804 and the transcutaneous analyte sensor 24 to pass through to insertthe transcutaneous analyte sensor 24 into the individual's skin.

FIG. 62 illustrates other components of the applicator 832. Thecomponents may include an actuator that may be coupled to the applicatorhousing 834 and that is configured to insert the needle 804 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. Such an actuator may be referred to as aninsertion actuator. The insertion actuator may include components thatmay include a control device 836 and a driver 838, and may include acarriage 840. The insertion actuator may include other components (orfewer components) in other embodiments. The applicator 832 may include arelease actuator that is configured to release the needle 804 from areleasable coupler. The release actuator may include components that mayinclude the control device 836 and may include a lever arm 842 that isconfigured to move the releasable coupler to cause the needle 804 torelease from the releasable coupler. The release actuator may beconfigured to release the needle 804 from the releasable coupler toallow the needle 804 to be passed through the opening 881 at the bottomportion of the applicator housing 834. The release actuator may includeother components (or fewer components) in other embodiments. Theconfiguration of components in the applicator 834 may be varied in otherembodiments.

FIG. 63 illustrates a perspective view of the carriage 840 of theinsertion actuator. The carriage 840 may comprise a body configured toslide within an interior cavity of the applicator 832 that may bedefined by the applicator housing 834. The carriage 840 may beconfigured to slide relative to the applicator housing and be configuredto be slid by the driver 838. The carriage 840 may include an outer ring844. The outer ring 844 may surround a cavity 846 of the carriage 840.The cavity 846 may be configured to receive a driver 838 (marked in FIG.62) of the insertion actuator.

The carriage 840 may include a central body 848 that spans the interiorof the outer ring 844 of the carriage 840. An upper surface of centralbody 848 of the carriage 840 may include a releasable coupler 850configured to couple to a coupling member 852 of the insertion actuatoras shown in FIG. 67. The releasable coupler 850 may comprise a U-shapedbody having a central opening that the coupling member 852, which may bein the form of a ledge, is configured to extend into. The U-shaped bodyextends upward from the central body 848 and is configured to bedeflectable to bend off of the ledge of the insertion actuator, torelease the releasable coupler 850 from the ledge. The releasablecoupler 850 may also be configured to engage and be released from acoupling member 854 of the control device 836 (marked in FIG. 68). Inother embodiments, the releasable coupler 850 may have different forms.

An upper surface of central body 848 of the carriage 840 may includestops 856 a, b that extend upward from the central body 848 to contact aportion of the control device 836 to impede movement of the controldevice 836 at a desired time. The upper surface of the central body 848may include a column 858 having a pivot 860 at an upper portion of thecolumn 858. The column 858 may include a cavity 863 for receiving thelever arm 842. The pivot 860 may be configured to couple to the leverarm 842 for the lever arm 842 to pivot about.

FIG. 64 illustrates a perspective view of a lower surface of thecarriage 840. The lower surface of the carriage 840 may include areceiver 862 that is configured to receive at least a portion of thetranscutaneous analyte sensor system. The receiver 862 may comprise acavity that is configured to receive the transcutaneous analyte sensorsystem. The receiver 862 may include at least one releasable coupler 864a, b that is configured to couple to the wearable housing 108 of thetranscutaneous analyte sensor system. The releasable coupler 864 a, bmay comprise a protrusion configured to enter into a cavity 123 (markedin FIG. 3) of the housing 108 to couple to the housing 108. In otherembodiments, other forms of releasable couplers 864 a, b may beutilized.

An opening 865 may be positioned on the carriage 840 and may extendthrough the lower surface of the central body 848. The opening 865 maybe configured for the needle cover 802 to be positioned in when thehousing 108 is positioned within the receiver 862.

FIG. 65 illustrates a perspective view of the lever arm 842 of therelease actuator. The lever arm 842 may include a releasable coupler 866that is configured to releasably couple to the needle 804. Thereleasable coupler 866 may include hooks 868 a, b that are configured toengage coupling members 869 a, b (marked in FIG. 60) of the needle cover802 to releasably couple to the needle 804. The coupling members 869 a,b may comprise protrusions that extend outward from the sides of theneedle cover 802. The releasable coupler 866 may be configured to retainthe needle 804 at least partially within the applicator housing 834following insertion of the transcutaneous analyte sensor 24 into theindividual's skin and removal of the applicator housing 834 from thetranscutaneous analyte sensor 24, and configured to release the needle804 from within the applicator housing 834 following insertion of thetranscutaneous analyte sensor 24 into the individual's skin.

The lever arm 842 may include pivot pins 870 that engage the pivot 860of the column 858 and allow the lever arm 842 to rotate about the pivot.A biasing spring 872 (marked in FIG. 67) may bias the lever arm 842 in adirection away from the column 858. The configuration of the lever arm842 may be varied in other embodiments.

FIG. 66 illustrates a rear perspective view of the control device 836 ofthe insertion actuator and the release actuator. The control device 836may comprise a button that may be pressed or other body that may bemoved to activate the insertion actuator and activate the releaseactuator. The control device 836 may be configured to be slid laterallyto activate the insertion actuator and activate the release actuator.The control device 836 may include a button surface 874 (marked in FIG.62) and a control arm 876 that extends from the button surface 874. Thecontrol arm 876 may include coupling members 854 in the form ofprotrusions extending in a parallel direction with the control arm 876.The control arm 876 may further include pressing surfaces 879 that areconfigured to press the releasable coupler 850 of the carriage 840 shownin FIG. 63. The control arm 876 may include further pressing surfaces880 a, b that are configured to press against the lever arm 842. Thecontrol arm 876 may include openings 882 configured to receive the stops856 a, b of the carriage 840, to impede movement of the control device836.

FIG. 67 illustrates a perspective cross sectional view of the applicator832 showing that the applicator housing 834 includes a receiver 878 forreceiving the cartridge 800. The receiver 878 may be configured for thecartridge 800 retaining the transcutaneous analyte sensor to be insertedinto. The receiver 878 may comprise a cavity within the applicatorhousing 834 that receives the cartridge 800. The cartridge 800 may beinserted into the receiver 878 axially through an opening 881 at abottom of the applicator housing 834.

FIG. 67 illustrates an assembled view of the components of theapplicator 832, showing the carriage 840 of the insertion actuatorwithin the applicator housing 834. The driver 838 of the insertionactuator may be positioned above the carriage 840 and between a springsupport body 883 of the applicator housing 834. The driver 838 may beconfigured to drive the needle 804 into the individual's skin to insertthe transcutaneous analyte sensor into the individual's skin. The leverarm 842 of the release actuator may be coupled to the pivot 860 shown inFIG. 63. The control device 836 may be inserted into an opening 884(marked in FIG. 62) of the side wall of the applicator housing 834. Thecontrol device 836 may be biased by a biasing spring 886 in a directionaway from a spring support surface 888 of the applicator housing.

The applicator 832 may operate in a manner shown in FIGS. 67-72. FIG. 67illustrates the cartridge 800 having been inserted into the receiver 878of the applicator housing 834. The releasable coupler 864 a, b of thecarriage 840 of the insertion actuator engages the wearable housing 108of the on-skin sensor assembly. A removable cover of the cartridge 800may previously have been removed by an individual.

FIG. 67 illustrates the applicator 832 after the cartridge 800 has beenfully inserted into the receiver 878 of the applicator housing 834. Thecartridge 800 may be inserted in the axial dimension of the applicatorhousing 834, which is the same dimension that the transcutaneous analytesensor 24 as well as other components of the transcutaneous analytesensor system will be deployed from the applicator housing 834 (althoughin an opposite axial direction that the cartridge 800 is inserted intothe receiver 878). The insertion of the cartridge 800 and thetranscutaneous analyte sensor 24 into the receiver 878 of the applicatorhousing 834 may compress and thus provide energy to the driver 838 ofthe insertion actuator. The driver 838 is compressed in theconfiguration shown in FIG. 67. In an embodiment in which the driver 838is a spring, the spring may be compressed by the insertion of thecartridge 800 and the transcutaneous analyte sensor 24 into thereceiver. The cartridge 800 may include a pressing surface on an uppersurface of the cartridge 800 to press against the carriage of theinsertion actuator to provide energy to the insertion actuator.

The insertion of the cartridge 800 fully into the receiver 878 of theapplicator housing 834 also causes the releasable coupler 850 of theinsertion actuator to engage the coupling member 852 of the insertionactuator. The engagement of the releasable coupler 850 holds thecarriage 840 of the insertion actuator in position and prevents thedriver 838 from pressing the carriage 840 in an axial direction towardsthe lower opening 881 of the applicator housing 834.

As shown in FIG. 67, the wearable housing 108 of the transcutaneousanalyte sensor system may be positioned in the receiver 862 of the lowersurface of the carriage 840. The releasable coupler 864 a, b shown inFIG. 64 may couple to the cavity 123 shown in FIG. 3 to grip thewearable housing 108 to the lower surface of the carriage. Thus, as thecartridge 800 is withdrawn from the applicator housing 834, the wearablehousing 108 remains coupled to the receiver 862.

The releasable coupler 866 couples to the needle 804, particularly withthe hooks 868 a, b of the releasable coupler 866 engaging the couplingmembers 869 a, b (marked in FIG. 60) of the needle cover 802.

The needle 804 is shown to extend downward from the wearable housing 108of the transcutaneous analyte sensor system, extending for insertion ofthe penetrating tip of the needle 804 into the individual's skin.

The cartridge 800 may be withdrawn from the applicator housing 834 toleave the transcutaneous analyte sensor system in position forapplication to the individual's skin by the applicator 832. Thetranscutaneous analyte sensor system may be moved axially downwardwithin the receiver 878 of the applicator housing 834 to contact theindividual's skin and be applied to the individual's skin.

The insertion actuator may operate to insert the needle 804 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. The control device 836 of the insertion actuatormay be pressed in a lateral direction, or a direction transverse to theaxial dimension of the applicator housing 834. The movement of thecontrol device 836 may compress the biasing spring 886 that isconfigured to apply a biasing force to the control device 836. Themovement of the control device 836 may disengage the releasable coupler850 from the coupling member 852, by the pressing surface 879 marked inFIG. 66 pressing against the upper “U” portion of the releasable coupler850.

Referring to FIG. 68, upon the pressing surface 879 marked in FIG. 66pressing against the upper “U” portion of the releasable coupler 850,the releasable coupler 850 may be pushed onto the coupling member 854 atthe end of the control arm 876. The releasable coupler 850 may rest uponthe coupling member 854. The stops 856 a, b of the carriage 840 of theinsertion actuator may insert into the openings 882 of the controldevice 836 to impede movement of the control device 836 such that thelever arm 842 is not pressed enough to cause the release actuator toactivate or such that the lever arm 842 is not pressed at all.

FIG. 69 illustrates the releasable coupler 850 supported upon thecoupling member 854 at the end of the control arm 876.

The control device 836 may be released in order to release the coupler850 from the coupling member 854 at the end of the control arm 876. Anindividual may release pressure on the button surface of the controldevice 836 to cause the biasing spring 886 (marked in FIG. 67) to movethe control device 836 in the opposite direction from which the controldevice 836 was pushed. Such an operation slides the coupling member 854at the end of the control arm 876 laterally, away from the coupler 850,and allows the coupler 850 to drop. FIG. 69 illustrates the couplingmember 854 at the end of the control arm 876 being slid away from thecoupler 850 to allow the coupler 850 to drop. The stops 856 a, b of thecarriage 840 of the insertion actuator also drop from the openings 882in the control arm 876.

FIG. 70 illustrates the carriage 840 of the insertion actuator havingbeen driven downward by the force from the driver 838. The force of thedriver 838 upon the carriage 840 causes the carriage 840 to descendrapidly with sufficient force to drive the needle 804 into theindividual's skin. Further, the movement of the carriage 840 has pressedthe patch 106 to the individual's skin, allowing the patch 106 to adhereto the individual's skin and providing an adhesive force to the skin forthe transcutaneous analyte sensor system.

With the needle 804 and the transcutaneous analyte sensor 24 insertedinto the individual's skin, the applicator housing 834 may be pulledaway from the individual's skin to withdraw the needle 804 from theskin. FIG. 71, for example, illustrates the applicator housing 834having been withdrawn from the individual's skin, with the on-skinsensor assembly 12 remaining positioned on the individual's skin. Thereleasable coupler 866 shown in FIG. 65 retains the needle 804 to theapplicator housing 834 following insertion of the transcutaneous analytesensor 24 into the individual's skin and removal from the applicatorhousing from the transcutaneous analyte sensor 24. The transcutaneousanalyte sensor 24 remains within the individual's skin as the applicatorhousing is removed from the transcutaneous analyte sensor 24.

With the applicator housing removed from the transcutaneous analytesensor 24, the spring 816 operates to rotate the needle 804 such thatthe needle enters the cavity 812 of the needle cover 802. The needle 804may rotate such that the needle cover 802 covers the used needle 804 andparticularly the penetrating tip of the needle 804.

With the needle 804 positioned within the needle cover 802, the releaseactuator may be operated to release the needle 804 from the releasablecoupler 866 marked in FIG. 70.

Referring to FIG. 72, the control device 836 of the release actuator maybe pressed laterally, in a direction transverse to the axial dimensionof the applicator housing 834, causing the pressing surface 880 a, b ofthe control device 836 shown in FIG. 66 to be moved in the lateraldirection. The pressing surface 880 a, b may press against the lever arm842 of the release actuator, causing the lever arm 842 to rotate aboutthe pivot 860 marked in FIG. 63. The movement of the lever arm 842 maycause the releasable coupler 866 to release the needle 804. The needle804 may drop from the applicator housing 834 as shown in FIG. 72. Theneedle 804 and needle cover 802 may be released from the applicatorhousing 834 with the needle cover 802 covering the penetrating tip ofthe needle 804. Accordingly, the same control device 836 may be operatedtwice to first operate the insertion actuator and then second to operatethe release actuator. The control device 836 may be operated in a firstoperation to activate the insertion actuator, and may be configured tobe operated in a second operation following the first operation toactivate the release actuator. In an embodiment in which the controldevice 836 is a button, the first operation may comprise pressing thecontrol device 836 and the second operation may comprise pressing thecontrol device 836 a second time. The same control device 836accordingly may be pressed twice to operate both the insertion actuatorand the release actuator.

The release actuator may be configured to release the needle 804 coveredby the needle cover 802 from the applicator housing 834 followinginsertion of the needle into the individual's skin. The releasablecoupler 866 configured to retain the needle 804 is configured to releasethe needle 804 positioned within the needle cover 802 from theapplicator housing. The needle 804 covered by the needle cover 802 mayform a unit that is released together from the applicator housing fordiscard.

The needle 804 may be released from the applicator housing 834 fordiscard, as the needle 804 may have been contaminated through theprocess of insertion within the individual's skin. The needle 804accordingly may be a single use needle that is configured to discardwithin a sharps container or other disposal area. The needle 804 mayremain sheathed within the needle cover 802 such that an individual doesnot contact the used needle 804 and be subject to the contamination ofthe needle 804 or otherwise be injured by the penetrating tip of theneedle 804. The needle 804 may remain locked in position within theneedle cover 802 such that an individual cannot access the contaminatedportion of the needle 804. The needle 804 and needle cover 802 togethermay form a unit for disposal following insertion into an individual'sskin and separation from the applicator housing.

Upon release of the needle 804 and needle cover 802 from the applicatorhousing 834, the applicator is in a configuration for deployment ofanother transcutaneous analyte sensor 24 and other components of atranscutaneous analyte sensor system. As such, the applicator 832 isconfigured for multiple uses, and is not intended to be discarded. Theapplicator 832 may be loaded with another cartridge 800 and the stepsdisclosed herein may repeat as desired.

FIG. 73 illustrates an embodiment of a needle 900 that may be configuredsimilarly as the needle 804 shown in FIG. 60. The needle 900, however,may include a lock 902 at a proximal end of the needle 900 that may lockthe needle 900 in position within the needle cover 904 also serving as aneedle hub shown in FIG. 74. The needle 900 may be utilized in a systemfor inserting a transcutaneous analyte sensor into an individual's skin.The needle 900 may include a “C” shaped body having a central channel906 for the transcutaneous analyte sensor 24 to extend along uponinsertion into the individual's skin. The needle 900 may include a pivot908 at a proximal end of the needle 900 that the needle 900 isconfigured to pivot about, to rotate into a cavity 910 of the needlecover 904.

Referring to FIG. 74, the needle cover 904 may include two sheath bodiesthat couple together to form a sheath configured to extend over at leasta portion of the needle 900, similar to the needle cover 802 shown inFIG. 60. The needle cover 904 may be configured to rotate relative tothe needle 900 to extend over at least a portion of the needle 900. Theneedle 900 may be configured to be moved relative to the needle cover904 to be positioned into the needle cover 904. The needle cover 904 isconfigured to cover at least a portion of the needle 900 following theneedle 900 inserting the transcutaneous analyte sensor into the skin ofthe individual. The needle cover 904 may include a coupling member 912(marked in FIG. 86) that is configured to couple to a releasable couplerof an applicator. The coupling member 912 may comprise protrusions thatextend outward from the body of the needle cover 904, similar to thecoupling members 869 a, b shown in FIG. 60 that extend outward from thesides of the needle cover 802. The needle cover 904 may be coupled tothe wearable housing 108 and configured to be separable from thewearable housing 108.

The two sheath bodies of the needle cover 904 may enclose the cavity 910that the needle 900 may be rotated into upon release from the wearablehousing 108. The two sheath bodies may be separated from each other todefine an opening 914 that the needle 900 may pass through to enter thecavity 910.

The needle 900 and needle cover 904 may be enclosed in a cartridge 916.The cartridge 916 be configured similarly as the cartridge 800 shown inFIG. 60. The cartridge 916 may include a body 918 having a base and awall 920. The base may form a bottom of the cartridge 916 that thecartridge 916 may be positioned upon. The base may form a flangeextending outward from the wall 920. The wall 920 may extend upward fromthe base, transverse to a direction that the base extends in. The wall920 may extend around and define a cavity 922 that may receivecomponents of the cartridge including the transcutaneous analyte sensor24 and the needle 900. The wall 920 may extend around at least a portionof the needle cover 904. The wall 920 may extend upward to an upperopening 924 that exposes the components retained by the body 918. Thewall 920 may including an inner surface configured to face inwardtowards a central portion of the cartridge 916 and the transcutaneousanalyte sensor 24 and an outer surface facing opposite the innersurface. The outer surface of the wall may be configured to bepositioned within at least a portion of an applicator. The outer surfaceof the wall may comprise a mating surface for a receiver of theapplicator, and may be contoured to a shape of an inner surface of thereceiver.

The wall 920 may be shaped similarly as the wall 146 discussed in regardto the cartridge 104 shown in FIG. 5. The body 918 may include aretainer 926 that may operate and be structured similarly as theretainer 152 discussed in regard to the cartridge 104.

The body 918 of the cartridge 916 may include a central cavity 930 thatis configured to receive the needle 900 when positioned within the body918 of the cartridge 916. The cartridge 916 may include a removablecover 932 that operates similarly as the cover 324 shown in FIG. 30. Thecomponents of the transcutaneous analyte sensor system may be retainedby the body 918 in a similar manner as discussed in regard to thecartridge 104, and the cartridge 916 may be utilized in a similar manneras the cartridge 104.

The cartridge 916 may be utilized with an applicator 934 as shown in anexploded view in FIG. 75. The applicator 934 comprises a transcutaneousanalyte sensor applicator, and is configured to apply other componentsof the transcutaneous analyte sensor system to the skin of an individualincluding the wearable housing 108 and patch 106 of the transcutaneousanalyte sensor system. The applicator may deploy all or a portion ofcomponents of an on-skin sensor assembly 12 to an individual's skin.

The applicator 934 comprises a reusable applicator, and may providereusable functionality in a similar manner as the applicator 102.

FIG. 75 illustrates components of the applicator 934. The applicator 934may include an applicator housing 936, which may comprise a singlecomponent or multiple components, similar to the housing of theapplicator 102. As shown in FIG. 75, the applicator housing 936 mayinclude a side cover body 938, a lower body 940, and an upper cap 942.The components of the applicator housing 936 may be coupled together toform a single applicator housing 936. The applicator housing 936 may beconfigured to be gripped by an individual to apply the transcutaneousanalyte sensor into the individual's skin, to be held during deploymentof the transcutaneous analyte sensor, as well as other components of atranscutaneous analyte sensor system. The applicator housing 936 mayhave a cylindrical shape with an outer surface configured to be grippedby an individual. Other shapes of the applicator housing 936 may beutilized as desired.

The applicator housing 936 may include a side portion (formed by theside cover body 938), a top portion (formed by the upper cap 942) and abottom portion including an opening 998 shown in FIG. 81 for thetranscutaneous analyte sensor to be deployed from to be inserted intothe individual's skin. The opening 998 may be configured for the needle900 and the transcutaneous analyte sensor 24 to pass through to insertthe transcutaneous analyte sensor 24 into the individual's skin.

FIG. 75 illustrates other components of the applicator 934. Thecomponents may include an actuator that may be coupled to the applicatorhousing 936 and that is configured to insert the needle 900 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. Such an actuator may be referred to as aninsertion actuator. The insertion actuator may include components thatmay include a control device 944 and a driver 946, and may include acarriage 948. The insertion actuator may include other components (orfewer components) in other embodiments.

The applicator 934 may include a release actuator that is configured torelease the needle 900 from a releasable coupler. The release actuatormay include components that may include a control device 944 and mayinclude a pressing surface 951 (marked in FIG. 80) that is configured toapply a force to a releasable coupler to cause the needle 900 to releasefrom the releasable coupler. The release actuator may be configured torelease the needle 900 from the releasable coupler to allow the needle900 to be passed through the opening 998 at the bottom portion of theapplicator housing. The release actuator may include other components(or fewer components) in other embodiments. The applicator 934 mayinclude a retraction actuator that is configured to retract the needle900 from the individual's skin following insertion of the transcutaneousanalyte sensor into the individual's skin. The retraction actuator mayinclude components that may include a driver 950 and a carriage 952. Theretraction actuator may include other components (or fewer components)in other embodiments. The configuration of components in the applicator934 may be varied in other embodiments.

FIG. 76 illustrates a perspective view of the carriage 948 of theinsertion actuator. The carriage 948 may comprise a body configured toslide within an interior cavity of the applicator 934 that may bedefined by the applicator housing 936. The carriage 948 may beconfigured to slide relative to the applicator housing and be configuredto be slid by the driver 946 of the insertion actuator. The carriage 948may include an outer ring 954. The outer ring 954 may surround a cavity956 of the carriage 948. The cavity 956 may be configured to receive thecarriage 952 (marked in FIG. 78) of the retraction actuator and may beconfigured to receive a driver 950 (marked in FIG. 75) of the retractionactuator.

The carriage 948 may include a central body 958 that spans the interiorof the outer ring 954 of the carriage 948. The outer ring 954 mayinclude a channel 960 (marked in FIG. 77) configured to receive the wall920 of the cartridge 916.

An upper surface of the carriage 948 may include a releasable coupler962 a, b configured to couple to a coupling member 963 a, b of theinsertion actuator as shown in FIG. 84. The releasable coupler 962 a, bmay comprise “U” shaped bodies having openings configured for thecoupling member 963 a, b of the insertion actuator to engage. Thecoupling member 963 a, b may comprise protrusions that enter into theopenings of the releasable coupler 962 a, b. In other embodiments, thereleasable coupler 962 a, b may have different forms.

A central channel 964 (marked in FIG. 81) may be provided that may beconfigured for the needle 900 and the needle cover 904 to be positionedin. The central channel 964 may be configured for the needle 900 to beretracted into upon operation of the retraction actuator. Guide channels966 a, b (marked in FIGS. 81 and 76) may be provided on sides of thecentral channel 964 for the coupling member 912 (marked in FIG. 86) ofthe needle cover 904 to slide in upon retraction of the needle 900.

Referring to FIG. 81, the carriage 948 may include a deflection surface965 that is configured for the needle cover 904 to contact to cause theneedle cover 904 to rotate onto the needle 900 when the needle isretracted. The deflection surface 965 may have an angled shape asdesired.

Referring back to FIG. 76, the upper surface of the carriage 948 mayinclude a support 968 for supporting the driver 946 of the insertionactuator.

FIG. 77 illustrates a perspective view of a lower surface of thecarriage 948. The lower surface of the carriage may include a receiver970 that is configured to receive at least a portion of thetranscutaneous analyte sensor system. The receiver 970 may comprise acavity that is configured to receive the transcutaneous analyte sensorsystem. The receiver 970 may include at least one releasable coupler 972a, b that is configured to couple to the wearable housing 108 of thetranscutaneous analyte sensor system. The releasable coupler 972 a, bmay comprise a protrusion configured to enter into a cavity 123 (markedin FIG. 3) of the wearable housing 108 to couple to the wearable housing108. In other embodiments, other forms of releasable couplers 972 a, bmay be utilized.

An opening 974 may be positioned on the carriage 948 and may beconfigured to allow the needle 900 and needle cover 904 to be retractedinto the central channel 964. Further, the carriage 948 may include analignment rail 975 that is configured for the needle 900 to slideagainst to maintain a rotational orientation of the needle 900 as theneedle is retracted into the central channel 964. The needle 900 may bepositioned in axial alignment with the applicator 934 as the needle isretracted into the central channel 964. The alignment rail 975 may beconfigured to extend between portions of the needle cover 904 proximatethe needle 900.

The outer ring 954 of the carriage 948 may include coupling members 976for releasable couplers of the carriage 952 of the retraction actuatorto engage. The coupling members 976 may be positioned on the outersurface of the carriage 948 and may be in the form of protrusions asshown in FIG. 77.

FIG. 78 illustrates a top perspective view of the carriage 952 of therelease actuator. The carriage 952 may be configured to slide relativeto the applicator housing and be configured to be slid by the driver 950of the retraction actuator and the driver 946 of the insertion actuator.The carriage 952 may include releasable couplers 978 a, b for couplingto the coupling members 976 of the carriage 948 of the insertionactuator. The releasable couplers 978 a, b may comprise deflectable armsconfigured to extend over the coupling members 976 to engage with thecoupling members 976. The releasable couplers 978 a, b may be configuredto automatically release from the coupling members 976 of the carriage948 upon contact with a coupler release in the form of deflectors 980 a,b of the applicator housing, as shown in FIG. 87 along an inner sidewallof the applicator housing. The carriage 952 may include an opening 982configured for the support 968 and the driver 946 of the insertionactuator to extend through.

FIG. 79 illustrates a perspective view of a bottom surface of thecarriage 952 of the release actuator. The carriage 952 may include areleasable coupler 984 a, b that is configured to releasably couple tothe needle 900. The releasable coupler 984 a, b may include openings 986a, b that are configured to engage the coupling members 912 of theneedle cover 904 marked in FIG. 86 to releasably couple to the needle900. The openings 986 a, b may be movable upon a pressing surfacepressing upon arms 988 a, b (marked in FIG. 78) coupled to the openings986 a, b. The releasable coupler 984 a, b may be configured to retainthe needle 900 at least partially within the applicator housing 936following insertion of the transcutaneous analyte sensor 24 into theindividual's skin and removal of the applicator housing 936 from thetranscutaneous analyte sensor 24, and configured to release the needle900 from within the applicator housing 936 following insertion of thetranscutaneous analyte sensor 24 into the individual's skin. Theconfiguration of the carriage 952 may be varied in other embodiments.

FIG. 80 illustrates a perspective view of the control device 944 of boththe insertion actuator and the release actuator. The control device 944may comprise a button that may be pressed or another form of movablebody to activate the insertion actuator and to activate the releaseactuator. The control device 944 may be configured to be slid laterallyto activate the insertion actuator and to activate the release actuator.The control device 944 may include a button surface 990 (marked in FIG.75) and a control arm 992 that extends from the button surface 990. Thecontrol arm 992 may include a coupler release in the form of a pressingsurface 994 configured to be pressed against the releasable coupler 962a, b of the carriage 948 shown in FIG. 76 to release the releasablecoupler 962 a, b from the coupling member 963 a, b shown in FIG. 84. Thecontrol arm 992 may also include a coupler release in the form ofpressing surface 951 for pressing the arms 988 a, b shown in FIG. 78 torelease the releasable coupler 984 a, b. The pressing surfaces 994 mayextend further distally from the button surface 990 (marked in FIG. 75)than the pressing surface 951, and are staggered from the pressingsurface 951.

FIG. 81 illustrates a perspective cross sectional view of the applicator934 showing that the applicator housing 936 includes a receiver 996 forreceiving the cartridge 916. The receiver 996 may be configured for thecartridge 916 retaining the transcutaneous analyte sensor to be insertedinto. The receiver 996 may comprise a cavity within the applicatorhousing 936 that receives the cartridge 916. The cartridge 916 may beinserted into the receiver 996 axially through an opening 998 at abottom of the applicator housing 936.

The applicator 934 may operate in a manner shown in FIGS. 81-92. FIG. 81illustrates the applicator 934 in an initial state, in which theapplicator 934 is configured to receive the cartridge 916 and componentsof the transcutaneous analyte sensor system including the transcutaneousanalyte sensor 24, the wearable housing 108, and the patch 106.

The applicator 934 in the initial state has the carriage 948 of theinsertion actuator in a lowered state, proximate the lower opening 998of the applicator 934. The carriage 948 of the insertion actuator may bepressed to the lowered state by the force provided by the driver 946 ofthe insertion actuator. The driver 946 may be configured to drive theneedle 900 into the individual's skin to insert the transcutaneousanalyte sensor into the individual's skin. The carriage 952 of theretraction actuator may be in a raised state, pressed to the raisedstate by the force of the driver 950 of the retraction actuator. Thedriver 950 may be configured to drive the needle 900 out of theindividual's skin. The releasable couplers 978 a, b shown in FIG. 78 arenot yet coupling the carriages 948, 952 together.

The cartridge 916 may be inserted into the receiver 996 of theapplicator housing 936 to allow the releasable coupler 972 a, b of thecarriage 948 of the insertion actuator to engage the wearable housing108 of the on-skin sensor assembly. A removable cover 932 of thecartridge 916 may previously have been removed by an individual.

FIG. 82 illustrates the cartridge 916 being inserted into the receiver996 of the applicator housing 936. The cartridge 916 may be inserted inthe axial dimension of the applicator housing 936, which is the samedimension that the transcutaneous analyte sensor 24 as well as othercomponents of the transcutaneous analyte sensor system will be deployedfrom the applicator housing 936 (although in an opposite axial directionthat the cartridge 916 is inserted into the receiver 996). The insertionof the cartridge 916 and the transcutaneous analyte sensor 24 into thereceiver 996 of the applicator housing 936 may compress and thus provideenergy to both the driver 946 of the insertion actuator and the driver950 of the retraction actuator. Both drivers 946, 950 may be compressedfor example as shown in FIG. 84. In an embodiment in which the drivers946, 950 are springs, the springs may be compressed by the insertion ofthe cartridge 916 and the transcutaneous analyte sensor 24 into thereceiver. The cartridge 916 may include a pressing surface on an uppersurface of the cartridge 916 to press against the carriage of theinsertion actuator to provide energy to the insertion actuator.

The insertion of the cartridge 916 fully into the receiver 996 of theapplicator housing 936 causes the releasable couplers 978 a, b of theretraction actuator carriage 952 to engage the coupling members 976 ofthe insertion actuator carriage 948. FIG. 83, for example, illustrates aperspective view of the carriages 952, 948 coupled together.

The insertion of the cartridge 916 fully into the receiver 996 of theapplicator housing 936 also causes the releasable coupler 962 a, b ofthe insertion actuator to engage the coupling member 963 a, b as shownin FIG. 84. The engagement of the releasable coupler 962 a, b holds thecarriage 948 of the insertion actuator in position and prevents thedriver 946 from pressing the carriage 948 in an axial direction towardsthe lower opening 998 of the applicator housing 936.

As shown in FIG. 85, the releasable coupler 984 a, b couples to theneedle 900, particularly with the openings 986 a, b of the releasablecoupler 984 a, b engaging coupling members of the needle cover 904. Theneedle 900 extends downward from the wearable housing 108 of thetranscutaneous analyte sensor system, extending for insertion of thepenetrating tip of the needle 900 into the individual's skin.

As shown in FIG. 85, the wearable housing 108 of the transcutaneousanalyte sensor system may be positioned in the receiver 970 of the lowersurface of the carriage 948. The releasable coupler 972 a, b shown inFIG. 77 may couple to the cavity 123 shown in FIG. 3 to grip thewearable housing 108 to the lower surface of the carriage. Thus, as thecartridge 916 is withdrawn from the applicator housing 936, the wearablehousing 108 remains coupled to the receiver 970.

With the cartridge 916 withdrawn from the applicator housing 936, thetranscutaneous analyte sensor system is in position for application tothe individual's skin by the applicator 934. The transcutaneous analytesensor system may be moved axially downward within the receiver 996 ofthe applicator housing 936 to contact the individual's skin and beapplied to the individual's skin.

The insertion actuator may operate to insert the needle 900 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. The control device 944 of the insertion actuatormay be pressed in a lateral direction, or a direction transverse to theaxial dimension of the applicator housing 936. The movement of thecontrol device 944 may compress a biasing spring 999 (marked in FIG. 75)that is configured to apply a biasing force to the control device 944.

Referring to FIG. 86, the movement of the control device 944 maydisengage the coupling member 963 a, b from the releasable coupler 962a, b by the pressing surface 994 pressing the releasable coupler 962 a,b off of the coupling member 963 a, b. The force of the driver 946 ofthe insertion actuator upon the carriage 948 causes the coupledcarriages 948, 952 to descend rapidly with sufficient force to drive theneedle 900 into the individual's skin. The descent of the coupledcarriages 948, 952 is rapid enough such that the pressing surface 951does not contact the arms 988 a, b.

Referring to FIG. 87, after the control device 944 has been pressed andthe insertion actuator has been activated, the movement of the carriage948 has inserted the needle 900 into the individual's skin and hasinserted the transcutaneous analyte sensor 24 into the individual'sskin. Further, the movement of the carriage 948 has pressed the patch106 to the individual's skin, allowing the patch 106 to adhere to theindividual's skin and providing an adhesive force to the skin for thetranscutaneous analyte sensor system.

Further, with the carriages 948, 952 both being slid downward within theapplicator housing 936, the releasable couplers 978 a, b of theretraction actuator carriage 952 may contact the coupler release in theform of deflectors 980 a, b of the applicator housing 936. Such contactmay apply a force to the releasable couplers 978 a, b in lateraldirections that causes the releasable couplers 978 a, b to disengagefrom the protrusions of the coupling members 976. Accordingly, thecarriages 948, 952 may be decoupled from each other and able to sliderelative to each other. The retraction actuator accordingly may beconfigured to automatically operate upon the needle 900 inserting thetranscutaneous analyte sensor into the individual's skin.

Referring to FIG. 88, with the carriages 948, 952 decoupled from eachother, the driver 950 of the retraction actuator may apply an upwardforce to the carriage 952 of the retraction actuator to move thecarriage 952 upward.

The upward movement of the retraction actuator carriage 952 may causethe needle 900 that is coupled to the releasable coupler 984 a, b toretract out of the individual's skin, due to the upward movement of thereleasable coupler 984 a, b. The releasable coupler 984 a, b may causethe needle 900 to slide upwards.

Referring to FIG. 89, the needle 900 may slide upwards against thealignment rail 975, which extends between portions of the needle cover904 proximate the needle 900. The alignment rail 975 may allow theneedle 900 to stay in an axially vertical position as the needle isretracted upwards in the applicator housing 936. The needle cover 904,however, may be able to pivot relative to the needle 900.

FIG. 90, for example, illustrates the needle 900 being slid upward alongthe alignment rail 975, with the needle cover 904 contacting thedeflection surface 955. The needle cover 904 may rotate towards thepenetrating tip of the needle 900, yet may contact the wearable housing108 of the on-skin sensor assembly. This may stall the rotation of theneedle cover 904 until the applicator housing 936 is removed from thewearable housing 108 of the on-skin sensor assembly. With the applicatorhousing 936 removed from the wearable housing 108, the needle 900 maycontinue to slide upward in the central channel 964 and the needle cover904 may fully cover the needle 900. The needle 900 and needle cover 904may both be aligned axially within the central channel 964, as shown inFIG. 92. The retraction actuator may position the needle 900 into theneedle cover 904.

The lock 902 shown in FIG. 73 may lock with the needle cover 904, toprevent the needle cover 904 from rotating away from the needle 900.

The releasable coupler 984 a, b shown in FIG. 79 retains the needle 900to the applicator housing 936 following insertion of the transcutaneousanalyte sensor 24 into the individual's skin and removal from theapplicator housing from the transcutaneous analyte sensor 24. Thetranscutaneous analyte sensor 24 remains within the individual's skin asthe applicator housing is removed from the transcutaneous analyte sensor24.

With the applicator housing removed from the transcutaneous analytesensor 24, the release actuator may be operated to release the needle900 from the releasable coupler 984 a, b.

Referring to FIG. 91, the control device 944 of the release actuator maybe pressed laterally, causing the pressing surface 951 to apply a forceagainst the arms 988 a, b of the releasable couplers 984 a, b. The forceagainst the arms 988 a, b may cause the openings 986 a, b to releasefrom the coupling members 912 of the needle cover 904. Accordingly, thereleasable coupler 984 a, b may be released from the needle 900. Theneedle 900 and needle cover 904 may be released from the applicatorhousing 936 with the needle cover 904 covering the penetrating tip ofthe needle 900. The releasable coupler 984 a, b configured to retain theneedle 900 is configured to release the needle 900 positioned within theneedle cover 904 from the applicator housing. The needle 900 covered bythe needle cover 904 may drop from the applicator housing 936.

Accordingly, the same control device 944 may be operated twice to firstoperate the insertion actuator and then second to operate the releaseactuator. The control device 944 may be operated in a first operation toactivate the insertion actuator, and may be configured to be operated ina second operation following the first operation to activate the releaseactuator. In an embodiment in which the control device 944 is a button,the first operation may comprise pressing the control device 944 and thesecond operation may comprise pressing the control device 944 a secondtime. The same control device 944 accordingly may be pressed twice tooperate both the insertion actuator and the release actuator.

The needle 900 may be released from the applicator housing 936 fordiscard, as the needle 900 may have been contaminated through theprocess of insertion within the individual's skin. The needle 900accordingly may be a single use needle that is configured to discardwithin a sharps container or other disposal area. The needle 900 mayremain sheathed within the needle cover 904 such that an individual doesnot contact the used needle 900 and be subject to the contamination ofthe needle 900 or otherwise be injured by the penetrating tip of theneedle 900. The needle 900 may remain locked in position within theneedle cover 904 such that an individual cannot access the contaminatedportion of the needle 900. The needle 900 and needle cover 904 togethermay form a unit for disposal following insertion into an individual'sskin and separation from the applicator housing.

Upon release of the needle 900 and needle cover 904 from the applicatorhousing 936, and following the return of the control device 944 to theposition shown in FIG. 81, the applicator is in a configuration fordeployment of another transcutaneous analyte sensor 24 and othercomponents of a transcutaneous analyte sensor system. As such, theapplicator 934 is configured for multiple uses, and is not intended tobe discarded. The applicator 934 returns to a configuration shown inFIG. 81 for repeat of the steps shown in FIGS. 81-92. The applicator 934may be loaded with another cartridge 916 and the steps disclosed hereinmay repeat as desired.

FIGS. 93-106 illustrate a variation of the embodiment of FIGS. 73-92. Inthe embodiment of FIGS. 93-106, a pull tab or the like may be utilizedto release the used needle from the releasable coupler, although in someembodiments a release actuator, similar to other release actuatorsdisclosed herein may be utilized.

Referring to FIG. 93, a perspective view of a cartridge 1000 that may beconfigured similarly as the cartridge 916 shown in FIG. 74. Thecartridge 1000 may be configured to be inserted into an applicatorhousing and may retain a transcutaneous analyte sensor. The cartridge1000 may include a body configured to be coupled to an applicatorhousing and may include a retainer retaining the transcutaneous analytesensor and a wall extending around at least a portion of thetranscutaneous analyte sensor. The wearable housing 1001, including thetranscutaneous analyte sensor may be positioned within and retained bythe cartridge 1000, as well as the needle 1002 and the needle cover1004. The needle 1002 may be coupled to the needle cover 1004 at apivot, at which a coupling member 1006 may be positioned for engagementwith a releasable coupler of an applicator. The coupling member 1006 maycomprise protrusions that extend outward from the body of the needlecover 1004.

The needle cover 1004, referring to FIG. 94, may include a lock 1008that is configured to lock the needle 1002 in position within the needlecover 1004 upon rotation of the needle cover 1004 relative to the needle1002. The needle cover 1004 may be configured to rotate relative to theneedle 1002 to extend over at least the portion of the needle 1002. Theneedle cover 1004 may be configured to cover at least a portion of theneedle 1002 following the needle 1002 inserting the transcutaneousanalyte sensor into the skin of an individual.

The wearable housing 1001 may include indentations 1010 for engagementwith a releasable coupler of an actuator, for retaining the wearablehousing 1001 to the releasable coupler upon the cartridge 1000 beingremoved from an applicator.

In the cross sectional view of FIG. 94, the needle 1002 extends at anangle (e.g., a perpendicular angle) with respect to the needle cover1004. The needle hub 1012 coupled to the proximal portion of the needle1002 may include the lock 1008 and may be configured to rotate relativeto the needle cover 1004.

FIG. 95 illustrates a perspective view of a first carriage 1014 that maycomprise a retraction carriage for retracting the needle 1002 from theindividual's skin following insertion of the needle 1002. The carriage1014 may include releasable couplers 1016 that engage the wearablehousing 1001 to retain the wearable housing 1001 to the releasablecoupler 1016 upon the cartridge 1000 being removed from an applicator.The carriage 1014 may further include coupler releases in the form ofdeflectors 1018 configured to release a coupler to allow the carriage1014 to move relative to the insertion carriage 1020. The releasablecouplers 1022 may couple the insertion carriage 1020 to the carriage1014. The deflectors 1018, for example, may be configured to deflect thereleasable couplers 1022 of the insertion carriage 1020 shown in FIG. 97to release the carriages 1014, 1020 from each other. The releasablecouplers 1022 may be configured to automatically release upon contactwith the deflectors 1018. The releasable couplers 1022 may release thecarriages to allow the driver 1050 to move the carriage 1020 in adirection away from the carriage 1014. The first carriage 1014 mayfurther include protrusions 1021 that retain the first carriage 1014 tothe second carriage 1025.

The first carriage 1014 may further include releasable couplers 1023 forcoupling to the coupling member 1006 of the needle 1002, to withdraw theneedle 1002 from the individual's skin following insertion into theindividual's skin. One or more of the releasable couplers 1023 may beconfigured to retain a needle to the applicator housing followinginsertion of the transcutaneous analyte sensor into the individual'sskin and removal of the applicator housing from the transcutaneousanalyte sensor, and release the needle from within the applicatorhousing following insertion of the transcutaneous analyte sensor intothe individual's skin. The one or more releasable couplers 1023 may beconfigured to couple to a needle hub 1012 of the needle.

FIG. 96 illustrates a perspective view of a second carriage 1025 thatmay include support surfaces 1024 for the protrusions 1021 to contact tokeep the carriages 1014, 1025 engaged with each other. The secondcarriage 1025 may further include support surfaces 1026 for thereleasable couplers 1022 shown in FIG. 97 to engage with. The secondcarriage 1025 may further include a central channel 1028 for the firstcarriage 1014 to be positioned within.

FIG. 97 illustrates a bottom perspective view of the insertion carriage1020. The insertion carriage 1020 may include the releasable couplers1022 for engaging with the support surface 1026 of the second carriage1025. The insertion carriage 1020 may further include a releasablecoupler 1030 for engaging with the interior housing 1032 of theapplicator, and particularly with an aperture 1034 of the interiorhousing 1032. The insertion carriage 1020 may comprise a component of anactuator or insertion actuator that may be coupled to the applicatorhousing and configured to insert a needle and the transcutaneous analytesensor into the individual's skin. The insertion carriage 1020 may beconfigured to slide relative to the applicator housing and configured tobe slid by the driver 1048.

In assembly, the first carriage 1014 may be positioned within thechannel 1028 of the second carriage 1025, and the carriages 1014, 1025may be positioned within the central channel 1031 of the insertioncarriage 1020. The assembly may be positioned within the interiorhousing 1032 shown in FIG. 98.

FIG. 98 illustrates a perspective view of the interior housing 1032. Theinterior housing may include a central cavity for the assembly of thecarriages 1014, 1025, 1020 to be positioned within. The interior housing1032 may include an outer surface 1036 including the aperture 1034 forthe releasable coupler 1030 to pass through, to hold the assemblies inposition relative to the interior housing 1032. The interior housing1032 may further include an upper surface 1038 having biasing members1040 in the form of springs, and particularly leaf springs configured tobias the interior housing 1032 downward with respect to an outer housingof the applicator. The interior housing 1032 may include a lower openingat a bottom surface of the interior housing 1032 for the transcutaneousanalyte sensor, and the needle 1002 and housing 1001 to be deployedfrom.

FIG. 99 illustrates a three-quarters cross sectional perspective view ofthe applicator 1042, including carriages 1014, 1025, 1020 assembled andpositioned within the interior housing 1032 of the applicator housing.The applicator housing may be configured to be gripped by an individualto apply the transcutaneous analyte sensor into the individual's skin.The applicator housing may include a side portion, a top portion and abottom portion including an opening for the transcutaneous analytesensor to be deployed from to be inserted into the individual's skin.The receiver of the applicator housing may be configured to receive thecartridge 1000 through the opening of the bottom portion. The interiorhousing 1032 may be positioned within an outer housing 1044 and may beconfigured to slide within the outer housing 1044. The biasing members1040, for example, may press against the interior surface of the top ofthe outer housing 1044 to bias the interior housing 1032 towards thebottom opening 1043. A force applied upwards against the interiorhousing 1032, by the skin of an individual, for example, may move theinterior housing 1032 upwards within the outer housing 1044.

The outer housing 1044 may comprise an outer surface of the applicator1042, and may include a control device 1045 that may be activated tocause the transcutaneous analyte sensor to be inserted into theindividual's skin. For example, the control device 1045 may comprise abutton that is pressed to remove the releasable coupler 1030 of thecarriage 1020 from the aperture 1034 of the interior housing 1032.

The insertion carriage 1020 is shown to further include a deflectionsurface 1046 that may be utilized to deflect the needle cover 1004 uponretraction of the needle 1002 from the housing 1001.

A driver 1048 may comprise a spring and may be configured to drive theneedle into the individual's skin to insert the transcutaneous analytesensor into the individual's skin. The driver 1048 may be configured todrive the entire assembly downward towards the individual's skin toinsert the needle 1002 into the individual's skin. A driver 1050 maycomprise a component of a retraction actuator and may be configured todrive the needle out of the individual's skin. A driver 1050 maycomprise a spring, and may be configured to press against a surface 1047of the second carriage 1025, as shown in FIG. 96, to retract thecarriages 1025, 1014, to retract the needle from the individual's skin.A driver 1055 may comprise a spring, and further may be utilized to biasthe first carriage 1014 and the second carriage 1025 from each other.

FIGS. 99-106 illustrate steps of a method that may utilize theapplicator 1042. In the initial configuration, the interior housing 1032may be biased downward with respect to the outer housing 1044 via thebiasing members 1040 shown in FIG. 98. Further, the releasable coupler1030 may be disengaged with the aperture 1034, and the driver 1048 maydrive the carriage 1020 to be positioned downward at this point. Thereleasable coupler 1022 may not yet be engaged with the support surface1026 at this point.

The cartridge 1000 may be inserted into the receiver of the applicator1042 by being inserted into the receiver. Upon insertion, aconfiguration as shown in FIG. 100 may result. The cartridge 1000 may beinserted into the applicator housing to provide energy to the insertionactuator and the retraction actuator. The insertion of the cartridge1000 may provide energy to the drivers 1048, 1050, 1055. In anembodiment in which the drivers 1048, 1050, 1055 comprise springs, theinsertion of the cartridge into the receiver may compress the springs. Aforce applied by the cartridge 1000 to the insertion and retractionactuators may provide energy to the respective actuators. The cartridge1000 for example may include a pressing surface for pressing against anactuator to provide energy to the actuator.

The cartridge 1000 may be inserted to contact the insertion carriage1020 and drive the insertion carriage 1020 upward. The driver 1048 maybe compressed. The releasable coupler 1030 may move to engage theaperture 1034 of the interior housing 1032 marked in FIG. 99. Thereleasable couplers 1023 of the carriage 1014 may start to engage thecoupling members 1006 of the needle 1002.

The cartridge 1000 may continue to be inserted until the releasablecouplers 1023 of the carriage 1014 fully engages the coupling members1006 of the needle 1002. FIG. 101, for example, illustrates fullengagement, at which point the cartridge 1000 may be withdrawn from thereceiver of the applicator 1042. The cartridge 1000 may be removed fromthe applicator housing prior to the needle being inserted into theindividual's skin to insert the transcutaneous analyte sensor into theindividual's skin. The releasable coupler 1030 may fully engage theaperture 1034 of the interior housing 1032. The releasable coupler 1022may further engage the support surface 1026 of the second carriage 1025to couple the insertion carriage 1020 to the first and second carriages1014, 1025.

The releasable coupler 1016 may further engage the indentations 1010 onthe housing 1001 to retain the housing 1001 when cartridge 1000 iswithdrawn.

With the cartridge 1000 withdrawn, the applicator 1042 may have aconfiguration as shown in FIG. 102. The interior housing 1032 maycontinue to be biased downward away from the top of the outer housing1044. In such a configuration, the releasable coupler 1030 of theinsertion carriage 1020 may be offset from the position of the controldevice 1045, such that pressing the control device 1045 does not actuateinsertion of the needle 1002. Such a feature may serve as a safetyfeature to reduce the possibility of inadvertent actuation of the needle1002 prior to a desired time (at which the bottom surface 1051 of theinterior housing 1032 does not yet contact the individual's skin).

FIG. 103 illustrates the bottom surface 1051 of the interior housing1032 in contact with the individual's skin to overcome the bias of thebiasing members 1040. In such a configuration, the position of thereleasable coupler 1030 may be moved upwards to align with the controldevice 1045. As such, movement of the control device 1045 may result inthe releasable coupler 1030 being pressed to release the insertioncarriage 1020 from the interior housing 1032 and allow the driver 1048to drive the carriages 1014, 1025, 1020 downward.

FIG. 104, for example, illustrates the control device 1045 having beenpressed to release the releasable coupler 1030 from the aperture 1034 ofthe interior housing 1032. The driver 1048 drives the carriages 1014,1025, 1020 downward to press the needle 1002 into the individual's skinto deploy the transcutaneous analyte sensor into the individual's skin.The insertion carriage 1020 may remain coupled to the carriages 1014,1025 by the releasable coupler 1022 remaining coupled to the supportsurfaces 1026.

At this point, the releasable coupler 1022 may move relative to thecarriage 1014, and particularly the deflection surfaces 1018 of thecarriage 1014 to push the releasable coupler 1022 outward away from thesupport surfaces 1026 and off of the support surfaces 1026. As such, thedriver 1050 may drive the carriages 1014, 1025 upward relative to theinsertion carriage 1020 and may pull the needle 1002 upward by way ofthe coupling of the coupling member 1006 of the needle cover 1004 withthe releasable couplers 1023.

FIG. 105, for example, illustrates the carriages 1014, 1025 beingpressed upward by the driver 1050, and away from the insertion carriage1020. The needle cover 1004 may contact the deflection surface 1046,such that the retraction actuator comprising the carriages 1014, 1025and the driver 1050 rotates the needle 1002 into the needle cover 1004.The driver 1050 may slide the carriages 1014, 1025 relative to theapplicator housing. The retraction actuator may retract the needle fromthe individual's skin following insertion of the transcutaneous analytesensor into the individual's skin. The retraction actuator may beconfigured to automatically operate upon the needle inserting thetranscutaneous analyte sensor into the individual's skin. The retractionactuator may position the needle 1002 into the needle cover 1004, andmay rotate the needle 1002 into the needle cover 1004. The lock 1008shown in FIG. 94 may lock the needle 1002 into the needle cover 1004.

Referring to FIG. 106, with the needle 1002 covered by the needle cover1004, the unit of the needle 1002 and needle cover 1004 may be releasedfrom the releasable coupler 1023. The releasable coupler 1023 mayrelease the needle 1002 positioned within the needle cover 1004 from theapplicator housing. The needle 1002 may be separated from the applicatorhousing. The release may occur in a variety of manners. In embodiments,a pull tab as shown in FIGS. 107 and 108, for example, may be utilizedto pull on the needle cover 1004 and release the needle 1002 from thereleasable coupler 1023. In embodiments, a release actuator may beutilized, as disclosed herein. For example, a separate button may beutilized to release the unit of the needle 1002 and needle cover 1004may be released from the releasable coupler 1023.

The embodiments disclosed in regard to FIGS. 93-106 may be varied andcombined with other embodiments disclosed herein as desired.

FIG. 107 illustrates an embodiment of a cartridge 1100 that may includea pull tab 1102 that is configured to be pulled to release a needle froma releasable coupler. For example, the needle may be configuredsimilarly as the needle 1002 shown in FIGS. 93-106, and the releasablecoupler may be configured similarly as any of the releasable couplersfor a needle disclosed herein. The needle, for example, may bepositioned within a needle cover 1104 following insertion of the needleinto an individual's skin. The pull tab 1102 may be pulled to releasethe needle from the releasable coupler of the applicator.

The pull tab 1102 may be positioned within the cartridge 1100 prior toinsertion into the actuator, and may be packaged with the wearablehousing 1106, the needle, a patch 1107, and a transcutaneous analytesensor for implantation. The pull tab 1102, for example, may bepositioned upon the wearable housing 1106 as shown in FIG. 107, or maybe in another location such as surrounding the wearable housing 1106.The pull tab 1102 may be coupled to the needle cover 1104 or needle hubsuch that the pull tab 1102 descends from the needle cover 1104 with theneedle positioned therein, and is accessible to be pulled to release theneedle from a releasable coupler.

FIG. 108, for example, illustrates the pull tab 1102 after the needlehas been inserted into the individual's skin. The pull tab 1102 isaccessible for a user to grip (as shown) and pull to release the needlefrom the releasable coupler.

Any embodiment disclosed herein may utilize a pull tab.

The patch 1107 for the wearable housing 1106 may include a liner, and inembodiments, the cartridge 1100 may be coupled to the patch 1107 suchthat withdrawal of the cartridge from the wearable housing 1106 removesthe liner from the patch 1107. FIG. 109 for example, illustrates such aconfiguration, including a liner 1109 that is coupled to the cartridge1100. The liner 1109 may remain attached to the cartridge 1100 such thatfollowing withdrawal of the cartridge 1100 from the applicator andwearable housing 1106, the liner 1109 is removed from the patch 1107along with the cartridge 1100. For example, a step as shown in FIG. 101may result in the liner 1109 being removed. An adhesive layer of thepatch 1107 may remain for application to the individual's skin.

Such a feature may reduce the number of application steps of theindividual, as the liner 1109 would be automatically removed with theremoval of the cartridge 1100 from the applicator. Any embodimentdisclosed herein may utilize such a feature of a patch.

FIGS. 110-119 illustrate a variation of the embodiment of FIGS. 73-92.In the embodiment of FIGS. 110-119, a pull tab or the like may beutilized to release the used needle from the releasable coupler,although in some embodiments a release actuator, similar to otherrelease actuators disclosed herein may be utilized.

Referring to FIG. 110, a perspective view of a cartridge 1200 that maybe configured similarly as the cartridge 916 shown in FIG. 74. Thecartridge 1200 may be configured to be inserted into an applicatorhousing and may retain a transcutaneous analyte sensor. The cartridge1000 may include a body configured to be coupled to an applicatorhousing and may include a retainer retaining the transcutaneous analytesensor and a wall extending around at least a portion of thetranscutaneous analyte sensor. The wearable housing 1201, including thetranscutaneous analyte sensor may be positioned within and retained bythe cartridge 1200, as well as the needle 1202 (marked in FIG. 115) andthe needle cover 1204. The needle 1202 may be coupled to the needlecover 1204 at a pivot 1203. A coupling member 1206 may be positionedspaced from the pivot 1203 for engagement with a releasable coupler ofan applicator. The coupling member 1206 may comprise protrusions thatextend outward from the body of the needle cover 1204.

The needle cover 1204 may include a lock that may be configuredsimilarly as the lock shown in FIG. 94 and may be configured to lock theneedle 1202 in position within the needle cover 1204 upon rotation ofthe needle cover 1204 relative to the needle 1202. The needle cover 1204may further include a contact surface 1205 that may be contacted tocause the needle cover 1204 to pivot about the coupling member 1206. Theneedle cover 1204 may be configured to rotate relative to the needle1202 to extend over at least the portion of the needle 1202. The needlecover 1204 may be configured to cover at least a portion of the needle1202 following the needle 1202 guiding the transcutaneous analyte sensorinto the skin of an individual.

The wearable housing 1201 may include indentations 1210 for engagementwith a releasable coupler of an actuator, for retaining the wearablehousing 1201 to the releasable coupler upon the cartridge 1200 beingremoved from an applicator.

The needle 1202 extends at an angle (e.g., a perpendicular angle) withrespect to the needle cover 1204. The needle hub 1212 coupled to theproximal portion of the needle 1202 may include the lock and may beconfigured to rotate relative to the needle cover 1204.

FIG. 111 illustrates a perspective view of a first carriage 1214 thatmay be an insertion carriage configured to drive the needle 1202downward to insert the needle 1202 into the individual's skin. The firstcarriage 1214 may comprise a component of an actuator or insertionactuator that may be coupled to the applicator housing and configured toinsert a needle and the transcutaneous analyte sensor into theindividual's skin. The first carriage 1214 may be configured to sliderelative to the applicator housing and configured to be slid by thedriver 1237.

The carriage 1214 may include releasable couplers 1216 that engage thecoupling member 1206 to drive the needle 1212 downward and allow theneedle cover 1204 to pivot with respect to the releasable couplers 1216.The carriage 1214 may further include a central channel 1218 forsupports to extend through. The central channel 1218 may run through acentral shaft 1219. The first carriage 1214 may further include adeflection surface 1217 configured to deflect the needle cover 1204about the pivot 1203 and into the needle cover 1204.

One or more of the releasable couplers 1216 may be configured to retaina needle to the applicator housing following insertion of thetranscutaneous analyte sensor into the individual's skin and removal ofthe applicator housing from the transcutaneous analyte sensor, andrelease the needle from within the applicator housing followinginsertion of the transcutaneous analyte sensor into the individual'sskin. The one or more releasable couplers 1216 may be configured tocouple to a needle hub 1212 of the needle.

The first carriage 1214 may further include releasable couplers 1213 forengaging the indentations 1210 on the wearable housing 1201.

FIG. 112 illustrates a perspective view of a second carriage 1220 thatmay be a retraction carriage configured to retract the needle 1202 fromthe individual's skin. The second carriage 1220 may include a releasablecoupler 1222 and a pressing or contact surface 1224 configured to pressagainst the needle cover 1204 to retract the needle 1202. The secondcarriage 1220 may comprise a portion of a retraction actuator forretracting the needle 1202 and rotating the needle 1202 into the needlecover 1204. The retraction actuator may retract the needle 1202 from theindividual's skin following insertion of the transcutaneous analytesensor into the individual's skin.

The second carriage 1220 may further include a central channel 1226 forthe central shaft 1219 to pass through. The releasable coupler 1222 maybe configured to couple to a portion of the applicator housing to retainthe carriages 1220, 1214 in position. The releasable coupler 1222 may beconfigured to be pressed to release the carriage 1220. The secondcarriage 1220 may include a cavity 1228 for the first carriage 1214 tobe positioned in.

FIG. 113, for example, illustrates a three-quarters cross sectionalperspective view of an assembly of the carriages 1220, 1214 within thehousing of the applicator 1230. The applicator 1230 may include anapplicator housing having an outer housing 1232 and an interior housing1234, with the interior housing 1234 configured to slide relative to theouter housing 1232, similar to the embodiment shown in FIGS. 93-106. Theapplicator housing may be configured to be gripped by an individual toapply the transcutaneous analyte sensor into the individual's skin. Theapplicator housing may include a side portion, a top portion and abottom portion including an opening for the transcutaneous analytesensor to be deployed from to be inserted into the individual's skin.The receiver of the applicator housing may be configured to receive thecartridge 1000 through the opening of the bottom portion.

The interior housing 1234 for example, may be biased to extend downwardrelative to the outer housing 1232 as discussed regarding the biasingmembers 1040 (which may comprise springs or the like). The interiorhousing 1234 may include an aperture 1236 for engaging with thereleasable coupler 1222.

The outer housing 1232 may include a control device 1221 configured tobe actuated to insert the needle 1202 and operated by an individual.

The carriages 1220, 1214 may be positioned within the cavity of theinterior housing 1234. The carriage 1214 may be positioned within thecentral cavity of the carriage 1220.

A driver 1237, which may comprise a spring, may be positioned to drivethe carriages 1220, 1214 downward to insert the needle and thetranscutaneous analyte sensor into the individual's skin. A driver 1238(marked in FIG. 115), which may comprise a spring, may be positioned tobias the carriages 1220, 1214 away from each other.

FIGS. 113-119 illustrate steps of a method that may utilize theapplicator 1230. In the initial configuration, the interior housing 1234may be biased downward with respect to the outer housing 1232 viabiasing members. Further, the releasable coupler 1222 may be disengagedwith the aperture 1236, and the driver 1237 may drive the carriage 1220to be positioned downward at this point.

The cartridge 1200 may be inserted into the receiver of the applicator1230 by being inserted into the receiver. Upon insertion, aconfiguration as shown in FIG. 114 may result. The cartridge 1200 may beinserted into the applicator housing to provide energy to the insertionactuator. The force applied by the cartridge 1200 to the actuator mayprovide energy to the actuator. The insertion of the cartridge 1200 mayprovide energy to the driver 1237. In an embodiment in which the driver1237 comprises a spring, the insertion of the cartridge into thereceiver may compress the spring.

The cartridge 1200 may be inserted to contact the contact surface 1224of the carriage 1220 and drive the carriages 1220, 1214 upward. Thecartridge 1200 may include a pressing surface for pressing against theinsertion actuator for providing energy to the actuator. The driver 1237may be compressed. The releasable coupler 1222 may move to engage theaperture 1236 of the interior housing 1234. The releasable couplers 1216of the carriage 1214 may engage the coupling members 1206 of the needle1202.

The releasable couplers 1213 may further engage the indentations 1210 onthe housing 1201 to retain the housing 1201 when cartridge 1200 iswithdrawn.

The cartridge 1200 may be removed from the applicator housing prior tothe needle being inserted into the individual's skin to guide thetranscutaneous analyte sensor into the individual's skin.

With the cartridge 1200 withdrawn, the applicator 1230 may have aconfiguration as shown in FIG. 115. The interior housing 1234 maycontinue to be biased downward away from the top of the outer housing1232. In such a configuration, the releasable coupler 1222 of thecarriage 1220 may be offset from the position of the control device1221, such that pressing the control device 1221 does not actuateinsertion of the needle 1202. Such a feature may serve as a safetyfeature to reduce the possibility of inadvertent actuation of the needle1202 prior to a desired time (at which the bottom surface 1239 of theinterior housing 1234 does not yet contact the individual's skin).

FIG. 116 illustrates the bottom surface 1239 of the interior housing1234 in contact with the individual's skin to overcome the bias of thebiasing members. In such a configuration, the position of the releasablecoupler 1222 may be moved upwards to align with the control device 1221.As such, movement of the control device 1221 may result in thereleasable coupler 1222 being pressed to release the carriages 1220,1214 from the interior housing 1234 and allow the driver 1237 to drivethe carriages 1220, 1214 downward.

FIG. 117, for example, illustrates the control device 1221 having beenpressed to release the releasable coupler 1222 from the aperture 1236 ofthe interior housing 1234. The driver 1237 drives the carriages 1220,1214 downward to press the needle 1202 into the individual's skin todeploy the transcutaneous analyte sensor into the individual's skin.

At this point, the second carriage or retraction carriage 1220 maycontinue to be driven downward by the driver 1237. The second carriageor retraction carriage 1220 may move downward relative to the firstcarriage or the insertion carriage 1214. The force of the driver 1237may overcome the biasing force of the driver 1238. The contact surface1224 shown in FIG. 112 for example, may press against the contactsurface 1205 of the needle cover 1204 shown in FIG. 110, to cause theneedle cover 1204 to rotate. As such, the second carriage 1220 may serveas a retraction actuator configured to rotate the needle 1202 into theneedle cover 1204. The needle cover 1204 may pivot about the couplingmember 1206 and withdraw the needle 1202 from the individual's skin. Theretraction actuator may be configured to automatically operate upon theneedle 1202 inserting the transcutaneous analyte sensor into theindividual's skin.

The needle cover 1204 may pivot and contact the deflection surface 1217,to contact the needle hub 1212 and lock the needle 1202 into the needlecover 1204. FIG. 118, for example, illustrates the needle 1202 beingrotated into the needle cover 1204 due to the contact with the contactsurface 1205 of the needle cover 1204 and the contact of the needle hub1212 with the deflection surface 1217. The retraction actuator mayposition the needle 1202 into the needle cover 1204 and rotate theneedle 1202 into the needle cover 1204.

With the needle 1202 covered by the needle cover 1204, the unit of theneedle 1202 and needle cover 1204 may be released from the releasablecoupler 1216. The releasable coupler 1216 configured to retain theneedle 1202 may be configured to release the needle 1202 positionedwithin the needle cover 1204 from the applicator housing. The needle1202 may be separated from the applicator housing. The release may occurin a variety of manners. In embodiments, a pull tab as shown in FIGS.107 and 108, for example, may be utilized to pull on the needle cover1204 and release the needle 1202 from the releasable coupler 1216. Inembodiments, a release actuator may be utilized, as disclosed herein.For example, a separate button may be utilized to release the unit ofthe needle 1202 and needle cover 1204 may be released from thereleasable coupler 1223. FIG. 119, for example, illustrates the releaseof the unit of the needle 1202 and needle cover 1204 may be releasedfrom the releasable coupler 1216.

The embodiments disclosed in regard to FIGS. 110-119 may be varied andcombined with other embodiments disclosed herein as desired.

FIG. 120 illustrates an embodiment of a cartridge 1300 that may beconfigured similarly as the cartridge 300 shown in FIG. 30, yet mayinclude a needle hub 1302 that includes a releasable coupler 1304 thatis configured to couple to a coupling member 1306 (marked in FIG. 122)of the body 1308 of the cartridge 1300. The needle hub 1302 may furtherinclude coupling members 1307 configured to engage a releasable coupler1309 of the retraction actuator (marked in FIG. 125). The needle hub1302 may include a housing 1310 that is configured to extend over thewearable housing 108 of the on-skin sensor assembly. The cartridge 1300may be utilized in a system for inserting a transcutaneous analytesensor into an individual's skin.

Referring to FIGS. 120 and 121, a needle 1312 may have a proximal endcoupled to the needle hub housing 1310 and may extend from the needlehub housing 1310. The needle hub housing 1310 may include rails 1314that extend outward from the needle hub housing 1310. The rails 1314 maybe configured to slide along channels 1316 on the inner surface of thecartridge body 1308 to guide the needle hub 1302 as it slides axiallyrelative to the cartridge body 1308. The needle hub 1302 may include anopening 1317 configured to receive a carriage of the insertion actuator.

Referring to FIG. 121, the cartridge 1300 may include a body 1308 havinga base 1318 and a wall 1320. The base 1318 may form a bottom of thecartridge 1300 that the cartridge 1300 may be positioned upon. The base1318 may form a flange extending outward from the wall 1320. The wall1320 may extend upward from the base 1318, transverse to a directionthat the base 1318 extends in. The wall 1320 may extend around anddefine a cavity 1322 that may receive components of the cartridgeincluding the transcutaneous analyte sensor 24 and the needle 1312. Thewall 1320 may extend upward to an upper opening 1324 that exposes thecomponents retained by the body 1308. The wall 1320 may including aninner surface configured to face inward towards a central portion of thecartridge 1300 and the transcutaneous analyte sensor 24 and an outersurface facing opposite the inner surface. The outer surface of the wallmay be configured to be positioned within at least a portion of anapplicator. The outer surface of the wall may comprise a mating surfacefor a receiver of the applicator, and may be contoured to a shape of aninner surface of the receiver. The wall 1320 may be shaped similarly asthe wall 146 discussed in regard to the cartridge 104 shown in FIG. 5.

The cartridge 1300 may include an upper removable cover 1326 thatoperates similarly as the cover 324 shown in FIG. 30. The upperremovable cover 1326 may cover the upper opening 1324 of the cartridge1300. The cartridge 1300 may include a lower removable cover 1328. Thelower removable cover 1328 may be coupled to the base 1318 of thecartridge 1300 and may cover a lower opening 1330 of the cartridge 1300.The transcutaneous analyte sensor system 24 and the on-skin sensorassembly 12 may be configured to be deployed through the lower opening1330 of the cartridge. The lower removable cover 1328 may be configuredsimilarly as the upper removable cover 1326.

The body 1308 of the cartridge 1300 may include a protrusion 1331 thatis configured to align with a channel of the applicator housing to alignthe cartridge 1300 with the receiver of the applicator housing.

FIG. 122 illustrates a top perspective view of the cartridge 1300 withthe releasable coupler 1304 shown coupled to the coupling member 1306.

The cartridge 1300 may be utilized with an applicator 1332 as shown inan exploded view in FIG. 123. The applicator 1332 comprises atranscutaneous analyte sensor applicator, and is configured to applyother components of the transcutaneous analyte sensor system to the skinof an individual including the wearable housing 108 and patch 106 of thetranscutaneous analyte sensor system. The applicator may deploy all or aportion of components of an on-skin sensor assembly 12 to anindividual's skin.

The applicator 1332 comprises a reusable applicator, and may providereusable functionality in a similar manner as the applicator 102.

FIG. 123 illustrates components of the applicator 1332. The applicator1332 may include an applicator housing 1334, which may comprise a singlecomponent or multiple components, similar to the housing of theapplicator 102. As shown in FIG. 123, the applicator housing 1334 mayinclude a side cover body 1336, a lower body 1338, and an upper cap1340. The components of the applicator housing 1334 may be coupledtogether to form a single applicator housing 1334.

The applicator housing 1334 may be configured to be gripped by anindividual to apply the transcutaneous analyte sensor into theindividual's skin, to be held during deployment of the transcutaneousanalyte sensor, as well as other components of a transcutaneous analytesensor system. The applicator housing 1334 may have a cylindrical shapewith an outer surface configured to be gripped by an individual. Othershapes of the applicator housing 1334 may be utilized as desired.

The applicator housing 1334 may include a side portion (formed by theside cover body 1336), a top portion (formed by the upper cap 1340) anda bottom portion including an opening 1358 shown in FIG. 127 for thetranscutaneous analyte sensor to be deployed from to be inserted intothe individual's skin. The opening 1358 may be configured for the needle1312 and the transcutaneous analyte sensor 24 to pass through to insertthe transcutaneous analyte sensor 24 into the individual's skin.

FIG. 123 illustrates other components of the applicator 1332. Thecomponents may include an actuator that may be coupled to the applicatorhousing 1334 and that is configured to insert the needle 1312 into theindividual's skin to deposit the transcutaneous analyte sensor 24 intothe individual's skin. Such an actuator may be referred to as aninsertion actuator. The insertion actuator may include components thatmay include a control device 1342 and a driver 1344, and may include acarriage 1346. The insertion actuator may include other components (orfewer components) in other embodiments. The insertion actuator may beconfigured to insert the needle 1312 into the individual's skin with thecartridge 1300 positioned in the receiver 1386 of the applicator housingand remaining coupled to the applicator housing 1334. An individual mayleave the cartridge 1300 in the receiver during insertion of the needleand transcutaneous analyte sensor 24. The receiver 1386 may beconfigured to release the cartridge 1300 from the applicator housing.

The applicator 1332 may include a release actuator that is configured torelease the needle 1312 from a releasable coupler 1309 shown in FIG.125. The release actuator may include components that may include thecontrol device 1342 and may include a pressing surface 1348 (marked inFIG. 126) that is configured to apply a force to a releasable coupler tocause the needle 1312 to release from the releasable coupler 1309. Thereleasable coupler 1309 may be configured to retain the needle 1312 atleast partially within the applicator housing 1334 following insertionof the transcutaneous analyte sensor 24 into the individual's skin andremoval of the applicator housing 1334 from the transcutaneous analytesensor 24, and configured to release the needle 1312 from within theapplicator housing 1334 following insertion of the transcutaneousanalyte sensor 24 into the individual's skin. The release actuator mayinclude other components (or fewer components) in other embodiments.

The applicator 1332 may include a retraction actuator that is configuredto retract the needle 1312 from the individual's skin followinginsertion of the transcutaneous analyte sensor into the individual'sskin. The retraction actuator may include components that may include adriver 1350 and a carriage 1352. The retraction actuator may includeother components (or fewer components) in other embodiments.

The applicator 1332 may further comprise a biasing carriage 1354including a biasing surface 1356 configured to bias the cartridge 1300towards a lower opening 1358 of the applicator 1332. The biasingcarriage 1354 may be biased towards the lower opening 1358 of theapplicator 1332 by way of a biasing spring 1360 that presses against asurface 1361 of the biasing carriage 1354. The biasing carriage 1354 mayinclude stops 1362 that may be configured to impede movement of thecontrol device 1342.

FIG. 124 illustrates a perspective view of the carriage 1346 of theinsertion actuator. The carriage 1346 may comprise a body configured toslide within an interior cavity of the applicator 1332 that may bedefined by the applicator housing 1334. The carriage 1346 may beconfigured to slide relative to the applicator housing and be configuredto be slid by the driver 1344. The carriage 1346 may include a pressingbody 1364 that may be in the shape of a column and is configured topress against the needle hub 1302 shown in FIG. 121. The pressing body1364 may be configured to enter the opening 1317 of the needle hub 1302.An upper portion of the carriage 1346 may include a channel 1366 that isconfigured to receive the driver 1350 of the retraction actuator. Theupper portion of the carriage 1346 may include an opening 1368 that isconfigured to receive the driver 1344 of the insertion actuator.

An outer surface 1370 of the upper portion of the carriage 1346 mayinclude coupling members 1372 configured to couple to releasablecouplers 1374 of the carriage 1352 of the retraction actuator. Thecoupling members 1372 may be in the form of protrusions or another formof coupling member.

FIG. 125 illustrates a perspective view of the carriage 1352 of theretraction actuator. The carriage 1352 may be configured to sliderelative to the applicator housing and be configured to be slid by thedriver 1350. The driver 1350 may be configured to drive the needle 1312out of the individual's skin. The carriage 1352 may include releasablecouplers 1374 for coupling to the coupling members 1372 of the carriage1346 of the insertion actuator. The releasable couplers 1374 maycomprise deflectable arms configured to extend over the coupling members1372 to engage with the coupling members 1372. The releasable couplers1374 may be configured to automatically release from the couplingmembers 1372 of the carriage 1346 upon contact with a coupler release inthe form of deflectors 1376 of the applicator housing, as shown in FIG.132. The retraction actuator accordingly may be configured toautomatically operate upon the needle 1312 inserting the transcutaneousanalyte sensor into the individual's skin.

The carriage 1352 may include a releasable coupler 1309 that isconfigured to releasably couple to the needle 1312. The releasablecoupler 1309 may include openings that are configured to engage thecoupling members 1307 of the needle hub 1302 to releasably couple to theneedle 1312. The openings of the releasable coupler 1309 may be movableupon a coupler release in the form of pressing surface 1348 of thecontrol device 1342 (marked in FIG. 126) pressing upon arms 1378 of thereleasable coupler 1309.

FIG. 126 illustrates a perspective view of the control device 1342 ofboth the insertion actuator and the release actuator. The control device1342 may comprise a button that may be pressed or another body that maybe moved to activate the insertion actuator and to activate the releaseactuator. The control device 1342 may be configured to be slid laterallyto activate the insertion actuator and to activate the release actuator.The control device 1342 may include a button surface 1380 (marked inFIG. 123) and a control arm 1382 that extends from the button surface1380. The control arm 1382 may include a coupler release in the form ofpressing surface 1384 configured to be pressed against the releasablecoupler 1304 of the needle hub 1302 (marked in FIG. 122) to release thereleasable coupler 1304 from the coupling member 1306 shown in FIG. 122.The control arm 1382 may also include a pressing surface 1348 forpressing the arms 1378 shown in FIG. 125 to release the releasablecoupler 1309 (marked in FIG. 125). The control arm 1382 may furtherinclude a stop surface 1385 for contacting the stops 1362 of the biasingcarriage 1354 shown in FIG. 123.

FIG. 127 illustrates a perspective cross sectional view of theapplicator 1332 showing that the applicator housing 1334 includes areceiver 1386 for receiving the cartridge 1300. The receiver 1386 may beconfigured for the cartridge 1300 retaining the transcutaneous analytesensor to be inserted into. The cartridge 1300 may be coupled to theapplicator housing 1334 by being inserted into the receiver 1386. Thereceiver 1386 may comprise a cavity within the applicator housing 1334that receives the cartridge 1300. The cartridge 1300 may be insertedinto the receiver 1386 axially through the opening 1358 at the bottom ofthe applicator housing 1334.

The applicator 1332 may operate in a manner shown in FIGS. 127-136. FIG.127 illustrates the applicator 1332 in an initial state, in which theapplicator 1332 is configured to receive, and is receiving, thecartridge 1300 and components of the transcutaneous analyte sensorsystem including the transcutaneous analyte sensor 24, the wearablehousing 108, and the patch 106.

The applicator 1332 in the initial state has the carriage 1346 of theinsertion actuator in a lowered state, proximate the lower opening 1358of the applicator 1332. The carriage 1346 of the insertion actuator maybe pressed to the lowered state by the force provided by the driver 1344of the insertion actuator. The driver 1344 may be configured to drivethe needle 1312 into the individual's skin to insert the transcutaneousanalyte sensor into the individual's skin.

The carriage 1352 of the retraction actuator may be in a raised state,pressed to the raised state by the force of the driver 1350 of theretraction actuator. The releasable couplers 1374 shown in FIG. 125 arenot yet coupling the carriages 1352, 1346 together.

The cartridge 1300 may be inserted into the receiver 1386 of theapplicator housing 1334, with the removable covers 1326, 1328 of thecartridge 1300 having been previously removed by an individual. Thecartridge 1300 may be inserted in the axial dimension of the applicatorhousing 1334, which is the same dimension that the transcutaneousanalyte sensor 24 as well as other components of the transcutaneousanalyte sensor system will be deployed from the applicator housing 1334(although in an opposite axial direction that the cartridge 1300 isinserted into the receiver 1386). The insertion of the cartridge 1300and the transcutaneous analyte sensor 24 into the receiver 1386 of theapplicator housing 1334 may compress and thus provide energy to both thedriver 1344 of the insertion actuator and the driver 1350 of theretraction actuator. Both drivers 1344, 1350 may be compressed forexample as shown in FIG. 131. In an embodiment in which the drivers1344, 1350 are springs, the springs may be compressed by the insertionof the cartridge 1300 and the transcutaneous analyte sensor 24 into thereceiver.

The insertion of the cartridge 1300 fully into the receiver 1386 of theapplicator housing 1334 causes the releasable couplers 1374 of theretraction actuator carriage 1352 (marked in FIG. 125) to engage thecoupling members 1372 of the insertion actuator carriage 1346. FIG. 129,for example, illustrates a perspective view of the carriages 1346, 1352coupled together.

As shown in FIG. 128, the releasable coupler 1309 of the retractionactuator couples to the needle 1312, particularly with the openings ofthe releasable coupler 1309 engaging coupling members of the needle hub1302. The needle 1312 extends downward from the wearable housing 108 ofthe transcutaneous analyte sensor system, extending for insertion of thepenetrating tip of the needle 1312 into the individual's skin.

The cartridge 1300 notably may remain within the receiver 1386 of theapplicator housing 1334 during insertion of the needle 1312 andinsertion of the transcutaneous analyte sensor 24 into the individual'sskin, as well as deployment of the on-skin sensor assembly 12 to theindividual's skin.

Referring to FIG. 130, upon the cartridge 1300 being inserted into thereceiver 1386, the biasing surface 1356 of the biasing carriage 1354 maypress against the cartridge 1300 to bias the cartridge 1300 towards thelower opening 1358 of the applicator housing 1334. The biasing operationof the biasing carriage 1354 may keep the releasable coupler 1304 shownin FIG. 122 in a lowered position, beneath the range of motion of thepressing surface 1384 of the control device 1342 shown in FIG. 126. Suchan operation may prevent the applicator 1332 from deploying the needle1312 until a time that the base 1318 of the cartridge 1300 contacts theindividual's skin. As shown in FIG. 130, a gap 1387 may be positionedbetween an upper surface of the cartridge 1300 and a surface of theapplicator housing. The base 1318 of the cartridge 1300 may contact theindividual's skin and then be pressed upward to overcome the biasingforce of the biasing spring 1360 and be inserted further into thereceiver 1386 to close the gap 1387. Such a configuration may be shownin FIG. 131.

Further, as shown in FIG. 134, upon the cartridge 1300 being pressedfurther upward to overcome the biasing force of the biasing spring 1360and be inserted further into the receiver 1386, the stops 1362 of thebiasing carriage 1354 may be raised to impede undesired lateral movementof the control device 1342, such that the control device 1342 does notcontact the arms 1378 of the carriage 1352 of the retraction actuatorand undesirably release the needle 1312 from the releasable coupler 1309at this time. As such, the biasing carriage 1354 may act as a safetymechanism to prevent the needle 1312 from being deployed until a desiredtime, and prevent the needle 1312 to be released from the releasablecoupler 1309 until a desired time.

Referring to FIG. 131, with the cartridge 1300 fully inserted into thereceiver 1386, and with the base 1318 of the cartridge 1300 pressedagainst the individual's skin, the releasable coupler 1304 shown in FIG.122 may be in a raised position, within the range of motion of thepressing surface 1384 of the control device 1342.

The control device 1342 may be pressed laterally, compressing a biasingspring 1388 of the control device 1342. The pressing surface 1384 of thecontrol device 1342 may contact the releasable coupler 1304 of theneedle hub 1302 shown in FIG. 122, to release the releasable coupler1304 from the coupling member 1306. The force of the driver 1344 of theinsertion actuator causes the carriage 1346 of the insertion actuator topress against the wearable housing 108 and insert the needle 1312 andthe transcutaneous analyte sensor 24 into the individual's skin, anddeploy the other components of the on-skin sensor assembly 12 to theindividual's skin. The movement of the carriage 1346 has pressed thepatch 106 to the individual's skin, allowing the patch 106 to adhere tothe individual's skin and providing an adhesive force to the skin forthe transcutaneous analyte sensor system.

The needle hub 1302 may slide within the body of the cartridge 1300,with the rails 1314 of the needle hub 1302 sliding along the channels1316 on the inner surface of the cartridge body 1308.

Referring to FIG. 132, upon the carriages 1346, 1352 of the insertionactuator and the retraction actuator both descending within theapplicator housing 1334, the coupler release in the form of deflectors1376 of the applicator housing may contact the releasable couplers 1374,causing them to deflect and disengage from the coupling members 1372 ofthe insertion actuator carriage 1346. Accordingly, the carriages 1346,1352 may be decoupled from each other and able to slide relative to eachother. The force of the driver 1350 of the retraction actuator may causethe carriage 1352 of the retraction actuator to move upwards thusretracting the needle 1312 and the needle hub 1302 away from theindividual's skin. Such a configuration is shown in FIG. 133.

The releasable coupler 1304 as shown in FIG. 122 may further berecoupled to the coupling member 1306 shown in FIG. 122 due to themovement of the retraction actuator.

The releasable coupler 1309 retains the needle 1312 to the applicatorhousing 1334 following insertion of the transcutaneous analyte sensor 24into the individual's skin and removal from the applicator housing fromthe transcutaneous analyte sensor 24. The transcutaneous analyte sensor24 remains within the individual's skin as the applicator housing isremoved from the transcutaneous analyte sensor 24.

Referring to FIG. 134, notably, with the base 1318 of the cartridge 1300continuing to be pressed against the individual's skin, the stops 1362impede movement of the control device 1342 from contacting the arms1378. Thus, the needle 1312 cannot be released from the applicatorhousing 1334. The cartridge 1300 must be removed from the individual'sskin to allow the biasing carriage 1354 to press the cartridge 1300 in adirection towards the lower opening 1358 of the applicator housing 1334.With the cartridge 1300 pressed downward by the biasing carriage 1354,the gap 1387 is produced and the stop 1362 lowers beneath the stopsurface 1385 of the control device 1342.

As shown in FIG. 135, with the stops 1362 lowered, the control device1342 may be moved laterally to contact the arms 1378. As shown in FIG.136, the pressing surface 1348 of the control device 1342 may pressagainst the arms 1378, and release the releasable coupler 1309 shown inFIG. 125. The cartridge 1300, including the needle 1312 and needle hub1302 may be released from the applicator housing 1334 with the needle1312 positioned within the body 1308 of the cartridge.

The release actuator accordingly may operate to allow the cartridge 1300to be removed from the receiver of the applicator housing. The releaseactuator may unlock the cartridge 1300 from the applicator housing bythe releasable coupler 1309 releasing the cartridge 1300, and therebyreleasing the needle 1312 from the applicator housing. The needle 1312may be separated from the applicator housing by separating the cartridgefrom the applicator housing.

The same control device 1342 may be operated twice to first operate theinsertion actuator and then second to operate the release actuator. Thecontrol device 1342 may be operated in a first operation to activate theinsertion actuator, and may be configured to be operated in a secondoperation following the first operation to activate the releaseactuator. In an embodiment in which the control device 1342 is a button,the first operation may comprise pressing the control device 1342 andthe second operation may comprise pressing the control device 1342 asecond time. The same control device 1342 accordingly may be pressedtwice to operate both the insertion actuator and the release actuator.

The needle 1312 may be released from the applicator housing 1334 fordiscard, as the needle 1312 may have been contaminated through theprocess of insertion within the individual's skin. The needle 1312accordingly may be a single use needle that is configured to discardwithin a sharps container or other disposal area. The needle 1312 mayremain positioned within the body 1308 of the cartridge 1300 such thatan individual does not contact the used needle 1312 and be subject tothe contamination of the needle 1312 or otherwise be injured by thepenetrating tip of the needle 1312. For example, the wall 1320 of thecartridge 1300 may block access to the needle 1312. The cartridge 1300is configured to retain the needle after the cartridge 1300 has beenseparated from the receiver and the needle has been inserted into theindividual's skin. The needle 1312 may remain locked in position withinthe cartridge 1300 such that an individual cannot access thecontaminated portion of the needle 1312. The needle 1312 and otherportions of the cartridge 1300 together may form a unit for disposalfollowing insertion into an individual's skin and separation from theapplicator housing.

Upon release of the cartridge 1300 from the applicator housing 1334, andfollowing the return of the control device 1342 to the position shown inFIG. 133, the applicator is in a configuration for deployment of anothertranscutaneous analyte sensor 24 and other components of atranscutaneous analyte sensor system. As such, the applicator 1332 isconfigured for multiple uses, and is not intended to be discarded. Theapplicator 1332 returns to an initial configuration for repeat of thesteps shown in FIGS. 127-136. The applicator 1332 may be loaded withanother cartridge 1300 and the steps disclosed herein may repeat asdesired.

Variations of the applicator 1332 and cartridge 1300 may be provided.FIGS. 137-145 for example illustrate a variation of the applicator 1332and cartridge 1300 including the features disclosed herein.

Referring to FIG. 137, a cartridge 1400 may be provided that is similarto the cartridge 1300 shown in FIGS. 120-122, yet includes a needlecover 1402 over the needle 1404. The needle cover 1402 may be coupled tothe body 1406 of the cartridge 1400 and may extend through an opening inthe wearable housing 108 to cover the needle 1404. A wall of thecartridge 1400 may extend around at least a portion of the needle cover1402. The needle cover 1402 may cover all or a portion of the needle1404 (as shown in FIG. 137) and may comprise a sheath configured toextend axially along at least a portion of the needle shaft 1408. Theneedle cover 1402 may be configured to slide relative to the needle 1404as the needle 1404 penetrates the individual's skin. The needle 1404 maythus be configured to be moved relative to the needle cover 1402 to bepositioned into the needle cover 1402.

Beneficially, the needle cover 1402 may prevent an individual fromcontacting the penetrating tip of the needle 1404 prior to insertioninto the individual's skin, and following insertion into theindividual's skin. The needle cover 1402 is configured to cover at leasta portion of the needle 1404 following the needle 1404 inserting thetranscutaneous analyte sensor into the skin of the individual. Theneedle cover 1402 may be coupled to the wearable housing 108 andconfigured to be separable from the wearable housing 108.

The cartridge 1400 may include a coupling member 1407 on an outersurface of the cartridge 1400 for coupling with a releasable coupler1412 of the applicator 1410 as shown in FIG. 141.

FIG. 138 illustrates a perspective view of variations of the applicator1332. The applicator 1410 may be configured similarly as the applicator1332. The insertion actuator of the applicator 1410 may be configured toinsert the needle 1404 into the individual's skin with the cartridge1400 positioned in the receiver 1435 (marked in FIG. 140) of theapplicator housing. The applicator 1410, however, may include areleasable coupler 1412 in the form of a cartridge catch that retainsthe cartridge 1400 to the applicator housing 1413. The receiver 1435 maybe configured to release the cartridge 1400 from the applicator housing.

The releasable coupler 1412 may be pressed by a biasing spring 1414. Theapplicator 1410 may further include a coupler release in the form of aslide arm 1416 that may be slid to press against the releasable coupler1412 to overcome the biasing spring 1414 and release the releasablecoupler 1412.

The applicator 1410 may further include additional biasing surfaces 1418that may be pressed by biasing springs 1420. The biasing surfaces 1418may be coupled to bodies 1419 configured to slide axially within theapplicator housing 1413. The biasing surfaces 1418 may be configured topress against upper surfaces of the cartridge 1400, to apply a downwardforce to the cartridge 1400.

The carriage 1424 of the insertion actuator may include stops 1426extending outward from arms 1428 of the carriage 1424. The stops 1426may be configured to contact portions of the biasing carriage 1430, toimpede movement of the biasing carriage 1430 at a desired time.

Referring to FIG. 139, in operation, the applicator 1410 may operate ina similar manner as the applicator 1332. The applicator 1410, however,may include a stop 1432 on the biasing carriage 1430 that contacts thecontrol device 1434 to impede lateral movement of the control device1434 such that the control device 1434 does not contact a releasablecoupler 1436 (marked in FIG. 142) configured similarly as the releasablecoupler 1304 shown in FIG. 122. The stop 1432 accordingly blocksmovement of the control device 1434 until the cartridge 1400 contactsand is pressed against the individual's skin to cause the cartridge 1400to fully insert into the receiver 1435 of the applicator housing 1413.Upon full insertion of the cartridge 1400 into the receiver 1435 of theapplicator housing 1413, the biasing carriage 1430 may be pressed upward(in a similar manner as discussed regarding the biasing carriage 1354).The upward movement of the biasing carriage 1430 may move the stop 1432upward, to remove contact between the stop 1432 and the control device1434, and to allow the control device 1434 to be slid laterally tocontact the releasable coupler 1436 (marked in FIG. 142).

FIG. 140 illustrates the cartridge 1400 positioned within the receiver1435 of the applicator housing 1413, with the biasing carriage 1430pressing against the cartridge 1400. The biasing spring 1438 presses thebiasing carriage 1430 pressing against the cartridge 1400.

FIG. 141 illustrates the cartridge 1400 fully inserted within thereceiver 1435 of the applicator housing 1413. The releasable coupler1412 couples to the coupling member 1407 of the cartridge 1400 to retainthe cartridge 1400 within the receiver of the applicator housing 1413.

Further, as shown in FIG. 141, with the cartridge 1400 fully insertedwithin the receiver 1435 of the applicator housing 1413, the stop 1432of the biasing carriage 1430 is lifted to allow for lateral movement ofthe control device 1434. As shown in FIG. 142, the control device 1434may be pressed laterally, to contact and release the releasable coupler1436. A stop 1441 on the cartridge 1400 may contact the control device1434 to impede further lateral movement of the control device 1434. Assuch, the control device 1434 may be blocked from contacting an end ofthe slide arm 1416 and may be blocked from contacting the arms of thecarriage 1440 of the retraction actuator that are coupled to thereleasable coupler 1442.

The operation of the insertion actuator to insert the needle 1404 andthe transcutaneous analyte sensor 24 into the individual's skin may bethe same as with the applicator 1332. Similarly, the operation of theretraction actuator to retract the needle 1404 may be the same as withthe applicator 1332. Further, as shown in FIG. 144, the releasablecoupler 1436 couples to the coupling member 1444, which is configuredsimilarly as the coupling member 1306 shown in FIG. 122.

However, as shown in FIG. 143, with the carriage 1424 of the insertionactuator in a lowered position, the stops 1426 of the carriage 1424contact and press against surfaces of the biasing carriage 1430. Assuch, the biasing carriage 1430 is blocked from moving downward upon theapplicator housing 1413 being withdrawn from the individual's skin. Thebiasing surfaces 1418 of the bodies 1419, however, continue to apply adownward biasing force against the cartridge 1400 as the cartridge 1400is withdrawn from the individual's skin (as shown in FIG. 144). As such,the stop 1441 on the cartridge 1400 shown in FIG. 142 lowers with thecartridge 1400, while the stop 1432 shown in FIG. 139 remains in araised positioned.

Referring to FIG. 145, in such a configuration of stops 1441, 1432, thecontrol device 1434 may freely move laterally to contact the arms 1446(marked in FIG. 144) of the retraction actuator to release thereleasable coupler 1442 from the needle hub 1448. Further, the controldevice 1434 may contact an end of the slide arm 1416 to press the slidearm 1416 laterally and press against the releasable coupler 1412. Assuch, the cartridge 1400 may be free to release from the receiver 1435of the applicator housing 1413, with the releasable coupler 1442released from the needle hub 1448 and with the needle cover 1402covering the needle 1404. The retraction actuator may position theneedle 1404 into the needle cover 1402. The cartridge 1400 is configuredto retain the needle after the cartridge 1400 has been separated fromthe receiver and the needle has been inserted into the individual'sskin.

The release actuator accordingly may operate to allow the cartridge 1400to be removed from the receiver of the applicator housing. The releaseactuator may unlock the cartridge 1400 from the applicator housing bythe releasable coupler 1442 releasing the cartridge 1400, and therebyreleasing the needle 1404 from the applicator housing 1413. Further, therelease actuator may operate the releasable coupler 1412 to unlock thecartridge 1400.

In a similar manner as discussed in regard to the applicator 1332, theapplicator 1410 may be in a configuration for receiving anothercartridge 1400 for deployment of an on-skin sensor assembly.

FIGS. 146-151 illustrate a further variation in which the cartridgeincludes the retraction actuator for retracting the needle from theindividual's skin following insertion of the transcutaneous analytesensor into the individual's skin. The retraction actuator may beconfigured to automatically operate upon the needle inserting thetranscutaneous analyte sensor into the individual's skin. FIG. 146, forexample, illustrates a construction of a cartridge 1500 including aretraction actuator 1502 positioned within the cartridge 1500. Thecartridge 1500 may otherwise be configured similarly as the cartridge1300 shown in FIG. 120, and may include an upper removable cover 1504, alower removable cover 1506, a body 1508 and may include the wearablehousing 1510, transcutaneous analyte sensor, and the needle 1512. Apatch 1513 may be coupled to the wearable housing 1510 and positionedwithin the cartridge 1500. A retraction carriage 1514 and driver 1516may be positioned within the cartridge 1500.

The retraction carriage 1514 may couple to a needle hub 1518 of theneedle 1512 and may include arms 1520 extending outward from the needlehub 1518 and configured to contact interior portions of the cartridge1500. The connection of the retraction carriage 1514 to the needle hub1518 may include a beveled surface 1522 that the driver 1516 may abut.

The cartridge 1500 may further include a carriage 1524 for pressing theneedle 1512 into the individual's body and pressing the patch 1513 andthe housing 1510 against the individual's skin. The carriage 1524 mayinclude a releasable coupler 1531 for coupling with a portion of thecontrol device 1523.

Further features such as locks 1526 (shown in FIG. 147) may be includedwith the cartridge 1500 for locking the cartridge 1500 to the applicatorhousing 1528. The locks 1526 may comprise a releasable couplerconfigured to retain the needle 1512 at least partially within theapplicator housing 1528 following insertion of the transcutaneousanalyte sensor 24 into the individual's skin and removal of theapplicator housing 1528 from the transcutaneous analyte sensor 24, andconfigured to release the needle 1512 from within the applicator housing1528 following insertion of the transcutaneous analyte sensor 24 intothe individual's skin. The releasable coupler may release the needle viathe cartridge 1500 being separated from the applicator housing 1528. Thereleasable coupler may be configured to release the cartridge 1500 fromthe applicator housing 1528 to release the needle from within theapplicator housing 1528.

FIG. 147 illustrates a three-quarters cross sectional view of theapplicator 1530 and the cartridge 1500. The applicator 1530 may beconfigured similarly as the applicator 1334 shown in FIGS. 123-136, withthe control device 1523 corresponding to the control device 1342, thebiasing carriage 1534 corresponding to the biasing carriage 1354, theinsertion carriage 1536 corresponding to the carriage 1346, and thedriver 1538 corresponding to driver 1344. The biasing spring 1540corresponds to biasing spring 1360. The applicator 1530 operates in asimilar manner as the application 1334, however, the retraction actuatoris within the cartridge 1500.

FIG. 147, for example, illustrates the retraction actuator in anundeployed state within the cartridge 1500. The driver 1516 of theretraction actuator that is configured to drive the needle out of theindividual's skin is compressed between the wearable housing 1510 andsupport arms 1542 extending upward from the carriage 1524. The carriage1514 may be configured to slide relative to the applicator housing andmay be configured to be slid by the driver 1516 of the retractionactuator. The support arms 1542 may be positioned between the driver1516 and the needle hub 1518, and may have ends positioned above thebeveled surface 1522 of the needle hub 1518. The support arms 1542 mayhold against the driver 1516 to prevent the driver 1516 from contactingthe arms 1520 of the retraction carriage 1514 until the desired time.The support arms 1542 may comprise releasable couplers that couple thecarriage 1524 to the retraction carriage 1514. The support arms 1542 mayrelease the carriage 1524 from the retraction carriage 1514 to allow thedriver 1516 to move the retraction carriage 1514 in a direction awayfrom the carriage 1524.

The interior portions of the cartridge 1500 may include stops 1544 thatthe arms 1520 may be configured to contact to impede downward movementof the retraction carriage 1514. During downward movement of theretraction carriage 1514 and the carriage 1524, the arms 1520 maycontact the stops 1544 to offset the position of the carriage 1524relative to the retraction carriage 1514 and cause the support arms 1542to slide relative to the beveled surface 1522. The sliding motion movesthe arms 1542 below the beveled surface 1522 and causes the arms 1542 tomove radially inward towards the needle hub 1518, thus releasing thedriver 1516 to press against the arms 1542 and retract the needle 1512.

FIG. 148, for example, illustrates the cartridge 1500 inserted into thereceiver of the applicator 1530. The biasing carriage 1534 is compressedto allow the control device 1523 to move in a similar manner asdescribed in regard to FIG. 131 for example. Upward pressure against thecartridge 1500 by the individual's skin presses the biasing carriage1534 upward, to move the stop 1533, and allow the control device 1523 tomove inward to be pressed.

The insertion of the cartridge 1500 and the transcutaneous analytesensor 24 into the receiver of the applicator housing 1528 may compressand thus provide energy to the driver 1538 of the insertion actuator.The driver 1538 may be compressed. In an embodiment in which the driver1538 includes a spring, the spring may be compressed by the insertion ofthe cartridge 1500 and the transcutaneous analyte sensor 24 into thereceiver.

The insertion carriage 1536 is compressed in a similar manner as theinsertion carriage 1346 and may be in contact with the carriage 1524 todrive the carriage 1524 downward.

The cartridge 1500 may remain within the receiver of the applicatorhousing 1528 during insertion of the needle 1512 and insertion of thetranscutaneous analyte sensor 24 into the individual's skin, as well asdeployment of the on-skin sensor assembly 12 to the individual's skin.

The control device 1523 may contact the releasable coupler 1531 torelease the releasable coupler 1531 in a similar manner as described inregard to FIG. 131 for example. The control device 1523 may pressagainst the releasable coupler 1531 to disengage the coupler 1531 from asurface and allow the insertion carriage 1536 to drive the carriage 1524downward.

FIG. 149 illustrates the descent of the carriage 1524. The carriage 1524may move downward to insert the needle 1512 into the individual's skinto insert the transcutaneous analyte sensor into the individual's skin.Further, the patch 1513 may be applied to the individual's skin with anadhesive. The retraction carriage 1514 may slide along with the carriage1524 due to an interference fit between the arms 1542 and the needle hub1518.

Referring to FIG. 150, with the needle 1512 inserted and the patch 1513applied, the arms 1520 may contact the stops 1544 to move the retractioncarriage 1514 upward with respect to the carriage 1524. The arms 1542may then move downward with respect to the beveled surface 1522, whichallows the arms 1542 to move radially inward with respect to the needlehub 1518. The inward movement of the arms 1542 may release the driver1516, which allows the retraction carriage 1514 to move upward due tothe force of the driver 1516.

The cartridge 1500 may be configured to retain the needle 1512 after thecartridge 1500 has been separated from the receiver and the needle 1512has been inserted into the individual's skin.

FIG. 151, for example, illustrates such a configuration, in which theretraction carriage 1514 has moved upward to withdraw the needle 1512from the individual's skin. The housing 1510 is excluded from view inFIG. 151.

The cartridge 1500 may then be withdrawn and discarded, to discard theused needle 1512. The actuator 1530 may return to the state shown inFIG. 147, for insertion of another cartridge.

Variations in the configuration of the cartridge may be provided. FIGS.152-158 for example, illustrate embodiments in which the cartridgesinclude a bottom surface with an opening for the transcutaneous analytesensor to be deployed from and a patch for the transcutaneous analytesensor coupled to the bottom surface and covering the opening. In suchembodiments, the transcutaneous analyte sensor may be configured toslide within the cartridge relative to the patch. The cartridge may beconfigured to allow the needle to slide within the cartridge relative tothe patch. The patch may be configured to be deployed to theindividual's skin from the bottom surface of the cartridge.

FIG. 152, for example, illustrates an embodiment of a patch 1600 thatmay be utilized. The patch 1600 may include an adhesive layer 1602 and aliner 1604 coupled to the adhesive layer 1602. The patch 1600 mayinclude a window 1607 such as a relatively thin portion, or an openingin the patch 1600 for the needle and transcutaneous analyte sensor topass through.

FIG. 153 illustrates a bottom view of the patch 1600. The liner 1604 mayinclude multiple portions, including a first portion 1606 and a secondportion 1608 each configured to be separately removable from theadhesive layer 1602 prior to application of the adhesive layer 1602.Each portion 1606, 1608 may include a respective tab 1610, 1612 that maybe gripped and pulled to remove the respective portion of the liner 1604to expose the adhesive portion of the adhesive layer 1602.

The patch 1600 may be sized to be positioned at the bottom of acartridge. FIG. 154, for example, illustrates such a configuration. Thecartridge 1614 may include a body 1616 configured to be coupled to anapplicator housing and including a bottom surface 1618 with an opening1620 (marked in FIG. 156) for the transcutaneous analyte sensor to bedeployed from. The patch 1600 spans the opening 1620 and covers theopening 1620. The patch 1600 is coupled to the bottom surface 1618 withan adhesive or other means of attaching the patch 1600 to the bottomsurface 1618. The liner layer 1604 may be removed prior to applicationof the patch 1600 to the individual's skin.

In embodiments, a retraction actuator may be positioned within thecartridge 1614 for retracting the needle from the skin of an individualfollowing insertion of the transcutaneous analyte sensor into theindividual's skin. The retraction actuator may be configured toautomatically operate upon the needle inserting the transcutaneousanalyte sensor into the individual's skin. FIG. 155, for example,illustrates a retraction actuator including a carriage 1617 and aretraction carriage 1621. The carriage 1621 may be configured to sliderelative to the applicator housing and may be configured to be slid bythe driver 1636 of the retraction actuator.

The retraction carriage 1621 may include arms 1622 that engagereleasable couplers 1624. The releasable couplers 1624 may couple thecarriage 1617 to the retraction carriage 1621. The releasable couplers1624 may release the carriage 1617 from the retraction carriage 1621 toallow the driver 1636 to move the retraction carriage 1621 in adirection away from the carriage 1617. The retraction carriage 1621 maycouple to a needle 1626 that is configured to insert the transcutaneousanalyte sensor into skin of an individual.

Referring to FIG. 156, a cross sectional view of the cartridge 1614 isshown. The cartridge 1614 is shown to include an interior surfaceincluding coupler releases 1628 that are configured to contact the arms1622 upon downward sliding movement of the carriage 1617. The couplerreleases 1628 deflect the arms 1622 upon contact, to release the arms1622 from the releasable couplers 1624. The arms 1622 may then slideupward to retract the needle 1626 away from the individual's skin.

As such, in operation, the cartridge 1614 may be in a configuration asshown in FIG. 156. The housing 1630, needle 1626, and transcutaneousanalyte sensor 1632 are spaced from the patch 1600. Upon an insertioncarriage passing downward through the opening 1619 of the cartridge 1614and pressing the carriage 1617 downward, the housing 1630, sensor 1632,and needle 1626 may be driven downward towards the patch 1600 and mayslide relative to the patch 1600. The adhesive layer of the patch 1600may be exposed and in contact with the individual's skin.

The cartridge 1614 may remain within the receiver of the applicatorhousing 1528 during insertion of the needle 1626 and insertion of thetranscutaneous analyte sensor 24 into the individual's skin, as well asdeployment of the on-skin sensor assembly 12 to the individual's skin.

The needle 1626 may penetrate through the patch 1600, or may passthrough an opening in the patch 1600. The needle 1626 may slide relativeto the patch 1600 to insert the sensor 1632 into the skin of anindividual. The needle 1626 may insert the sensor 1632 into theindividual's skin. The housing 1630 may be applied to the patch 1600 andmay adhere to the patch 1600 with an adhesive or other means ofconnection.

The retraction actuator may then engage, with the retraction carriage1621 being released due to the movement of the arms 1622, and the driver1636 driving the retraction carriage 1621 upwards to drive the needle1626 out of the individual's skin.

The cartridge 1600 may be configured to retain the needle 1626 after thecartridge 1600 has been separated from the receiver and the needle 1626has been inserted into the individual's skin.

FIGS. 157 and 158 illustrate an alternate configuration of theretraction carriage 1640 and the carriage 1642. The retraction carriage1640 in such an embodiment may include arms 1644 that are configured tobe pressed inward to disengage from releasable couplers 1646 to retractthe needle 1648. The arms 1644 may press against coupler releases 1650that may be positioned on the interior surface of the cartridge 1614upon the carriage 1621 sliding downwards towards the patch 1600. Thespring 1652 may press the retraction carriage 1640 upward relative tothe carriage 1642 to retract the needle 1648. FIG. 158, for example,illustrates a configuration of a deployed housing 1654 with the needle1648 retracted.

Various modifications of the embodiments of cartridges shown in FIGS.155-158 may be provided. For example, in embodiments, a separateretraction actuator may be provided outside of the cartridge, such as inan embodiment of FIGS. 120-145. In embodiments, certain components ofthe sensor system may be positioned directly on the patch. For example,in embodiments, the wearable housing may be positioned directly on thepatch, and the needle may comprise the only component sliding withrespect to the patch. In embodiments, other retraction methods of theneedle may be provided, such as rotation of the needle.

The embodiments of cartridges having a patch at a bottom surface maybeneficially reduce the possibility of the skin of the individualentering the cavity 1660 (marked in FIG. 156) of the cartridge. Such afeature may reduce variation in the angle of entry of the needle intothe individual's skin, and may space the individual's skin at a desireddistance from the needle prior to actuation of the needle. For example,if a certain speed of entry of the needle into the individual's skin isneeded, then spacing the needle from the skin will beneficially reducethe possibility of the skin being undesirably close to the needle suchthat the needle does not gain enough speed to properly penetrate theskin. Various other benefits may result. Any embodiment as disclosedherein may utilize patches at a bottom surface of a cartridge orapplicator.

In the embodiments discussed in regard to FIGS. 2-158, the electronicsunit 26 may be coupled to the wearable housing 108 of the on-skin sensorassembly after the on-skin sensor assembly is deployed to theindividual's skin. Further, in other embodiments, the electronics unit26 may be integral with the wearable housing 108 and deployed to theindividual's skin along with the wearable housing 108. In otherembodiments, the electronics unit 26 may be coupled to the housing 108prior to deployment of the wearable housing 108 to the individual'sskin. The electronics unit 26 may include a communication device for thetranscutaneous analyte sensor 24.

FIGS. 159 and 160 illustrate features of an embodiment in which theelectronics unit 26 is coupled to the wearable housing 108 prior todeployment of the wearable housing 108 to the individual's skin. FIGS.159 and 160 illustrate a system for inserting a transcutaneous analytesensor into an individual's skin. The wearable housing 108 may bepositioned in a receiver 1800 of an applicator 1802, which may beconfigured similarly as any of the applicators disclosed herein. Thereceiver 1800 may be of an applicator housing configured to be grippedto apply the transcutaneous analyte sensor into the individual's skin,or may be a receiver of a cartridge, for instance in an embodiment asshown in FIGS. 120-158.

The wearable housing 108 may include a coupler 1804 that is positionedon a bottom surface of the wearable housing 108. Thus, the electronicsunit 26 may be coupled to the wearable housing 108 via insertion on abottom surface of the wearable housing 108 to couple to the coupler1804.

A mounting base 1806 may be provided that is configured to retain theelectronics unit 26. The electronics unit 26 may be provided on themounting base 1806. The mounting base 1806 may be configured to applythe electronics unit 26 to the coupler 1804 for the transcutaneousanalyte sensor 24 when the transcutaneous analyte sensor is retained bythe receiver 1800, to couple the electronics unit 26 to thetranscutaneous analyte sensor 24.

The mounting base 1806 may include a receiver 1808 on an upper surface1810 of the mounting base 1806 that is configured to retain theelectronics unit 26. The mounting base 1806 may include one or more sidesurfaces 1812 that may be shaped to mate with an inner surface 1814 ofthe receiver 1800. The one or more side surfaces 1812 may extend betweenthe upper surface and a lower surface of the mounting base 1806. The oneor more side surfaces 1812 may be shaped to mate with an inner surfaceof the receiver 1800 of the applicator 1802. Protrusions 1807 may bepositioned on the one or more side surfaces 1812 that are configured toalign the mounting base 1806 with the receiver 1800.

The wearable housing 108 may be positioned in the receiver 1800 of theapplicator 1802, and the mounting base 1806 may be inserted into thereceiver 1800 of the applicator 1802 retaining the transcutaneousanalyte sensor 24 to couple the electronics unit 26 to the wearablehousing 108. The receiver 1800 of the applicator may comprise a cavityor other form of receiver. The receiver 1800 may be configured to retainthe transcutaneous analyte sensor within the cavity. The receiver 1800may include an inner surface 1805 extending between the lower portion ofthe receiver 1800 and the upper portion of the receiver 1800 andsurrounding the cavity. As shown in FIG. 159, the applicator housing mayinclude an opening 1803 for the mounting base 1806 to be passed throughto enter the cavity. The opening 1803 may be positioned at a bottomportion of the applicator housing.

The mounting base 1806 may be configured to be inserted into thereceiver 1800 of the applicator housing to apply the electronics unit 26to the coupler 1804 for the transcutaneous analyte sensor. Theelectronics unit 26 may be pressed into the coupler 1804 of the wearablehousing 108 or may be coupled to the wearable housing 108 via anothermethod. The electronics unit 26 may be coupled to the transcutaneousanalyte sensor 24 and may be in electrical connection with thetranscutaneous analyte sensor 24.

The mounting base 1806 may then be removed from the applicator housingprior to the needle inserting the transcutaneous analyte sensor into theindividual's skin, with the electronics unit 26 remaining coupled to thewearable housing 108. The mounting base 1806 may be separated from theelectronics unit 26. The wearable housing 108 and electronics unit 26together may then be deployed to the individual's skin in a mannerdisclosed herein. The transcutaneous analyte sensor 24 may be insertedinto the individual's skin while coupled to the electronics unit 26.

In one embodiment, the receiver of the applicator may comprise areceiver 212 as shown in FIG. 21 for example. The receiver of theapplicator may be positioned on a carriage of an insertion actuator forexample that is configured to insert a needle and a transcutaneousanalyte sensor into an individual's skin as represented in FIG. 21.

FIG. 160 illustrates a side view of an embodiment in which the receiver1800 forms at least a portion of a cartridge 1816 configured forinsertion into the applicator housing (for example, in an embodimentshown in FIGS. 120-158). The mounting base 1806 is configured to beinserted into the cartridge 1816 to apply the electronics unit to thecoupler 1804 for the transcutaneous analyte sensor. The mounting base1806 may be removed from the cartridge 1816 prior to the needleinserting the transcutaneous analyte sensor into the individual's skinand deployment of the wearable housing 108 to the individual's skin.

The features of the embodiments of FIGS. 159 and 160 may be utilizedwith any embodiment of applicator system disclosed herein.

FIGS. 161-166 illustrate an embodiment of an applicator system in whicha cartridge 1900 may be inserted into a side of the applicator 1902.FIG. 161 illustrates a system for inserting a transcutaneous analytesensor into an individual's skin. Referring to FIG. 161, the cartridge1900 may retain the needle 1904, the transcutaneous analyte sensor 24,and the housing of the on-skin sensor assembly. The cartridge 1900 mayinclude an inner cartridge body 1906 and an outer cartridge body 1908that the inner cartridge body 1906 may slide relative to. The innercartridge body 1906 may retain the needle 1904, the transcutaneousanalyte sensor 24, and the wearable housing of the on-skin sensorassembly.

The inner cartridge body 1906 may further include a needle retainer 1909for retaining the needle 1904 after the needle 1904 has been insertedinto the individual's skin.

The outer cartridge body 1908 may include a cocking surface 1910 thatmay be configured to press against a carriage 1912 of an insertionactuator to cock the insertion actuator and provide energy to the driver1914 (marked in FIG. 163) of the insertion actuator and the driver 1916(marked in FIG. 163) of a retraction actuator configured to retract theneedle 1904 following insertion of the transcutaneous analyte sensorinto the individual's skin. The outer cartridge body 1908 may furtherinclude protrusions in the form of rails 1918 configured to slide alongchannels 1920 of an applicator housing 1922 and align the cartridge 1900with the receiver of the housing.

FIG. 162 illustrates a top perspective view of the cartridge 1900showing the needle 1904 and the wearable housing 108 coupled to the bodyof the cartridge. The wearable housing 108 may be coupled to the innercartridge body 1906 such that the electronics unit 26 may be coupled tothe wearable housing 108 while the wearable housing 108 remains coupledto the inner cartridge body 1906. The body of the cartridge, forexample, may include a slot 1926 for the electronics unit 26 to bepassed into to couple to the wearable housing 108.

Referring back to FIG. 161, the applicator 1902 may include theapplicator housing 1922, which may contain the contents of theapplicator 1902 therein. The applicator housing 1922 may be configuredto be gripped to apply the transcutaneous analyte sensor into theindividual's skin.

The applicator housing 1922 may include a side portion (formed by one ormore side surfaces 1936), a top portion (formed by a top surface 1934)and a bottom portion including a bottom opening 1928 for thetranscutaneous analyte sensor to be deployed from to be inserted intothe individual's skin. The opening 1928 may be configured for the needle1904 and the transcutaneous analyte sensor 24 to pass through to insertthe transcutaneous analyte sensor 24 into the individual's skin. Theapplicator housing 1922 may include the top surface 1934 and one or moreside surfaces 1936 defining sides of the applicator housing 1922. Thebottom opening 1928 may define the opening 1928 that the transcutaneousanalyte sensor 24 and needle 1904 are inserted into the individual'sbody from, and that other components of the on-skin sensor assembly aredeployed from.

The applicator housing 1922 may include a side opening 1930 for thetranscutaneous analyte sensor 24 to be inserted into. The side opening1930 may define an entry to a receiver 1932 of the applicator housing1922 for receiving the cartridge 1900 through the side opening 1930. Thereceiver 1932 may be configured for the cartridge 1900 retaining thetranscutaneous analyte sensor to be inserted into. The receiver 1932 mayinclude a cavity for receiving the cartridge 1900 retaining thetranscutaneous analyte sensor. The side opening 1930 may be positionedtransverse to the axial dimension defined by the bottom opening 1928.

The applicator 1902 may include an insertion actuator, which may includethe carriage 1912 and the driver 1914 (marked in FIG. 163). Theinsertion actuator may further include a control device 1925 foractivating the insertion actuator. The insertion actuator may be coupledto the applicator housing 1922 and may be configured to insert a needleinto the individual's skin to insert a transcutaneous analyte sensorinto the individual's skin. The insertion actuator may be configured toinsert the needle 1904 into the individual's skin with the cartridge1900 positioned in the receiver 1932 of the applicator housing andremaining coupled to the applicator housing. The cartridge 1900 may beleft within the receiver 1932 during insertion of the needle 1904. Thereceiver 1932 may be configured to release the cartridge 1900 from theapplicator housing. The control device 1925 may comprise a button thatmay be pressed by an individual or another form of movable body forreleasing the carriage 1912. The control device 1925 may include abutton surface 1939 and a control arm 1941 extending from the buttonsurface 1939.

The applicator 1902 may include a retraction actuator for retracting theneedle 1904 from the individual's skin. The retraction actuator mayinclude the driver 1916 and a carriage 1924 (marked in FIG. 163). Thedriver 1916 may be configured to drive the needle 1904 out of theindividual's skin.

Referring to FIG. 163, the carriage 1912 of the insertion actuator mayinclude a releasable coupler 1938 that is configured to couple to acoupling member of the applicator housing 1922. The releasable coupler1938 may be positioned such that lateral movement of the control device1925 causes the control arm 1941 to press against the releasable coupler1938 to release the releasable coupler 1938. The carriage 1912 may beconfigured to slide relative to the applicator housing and be configuredto be slid by the driver 1914.

The carriage 1924 of the retraction actuator may include a releasablecoupler 1944 that is configured to couple to the carriage 1912 of theinsertion actuator. The releasable coupler 1944 may be configured tocontact a coupler release 1946 that may be positioned on the cartridge1900 to automatically release the coupler 1944. The carriage 1924 may beconfigured to slide relative to the applicator housing and be configuredto be slid by the drivers 1916 and 1914. A releasable coupler 1948 maybe coupled to a portion of the carriage 1924 of the retraction actuator.The releasable coupler 1948 may be configured to couple to the needle1904. The releasable coupler 1948 may be configured such that slidinglateral movement of the needle 1904 may release the needle 1904 from thereleasable coupler 1948. The releasable coupler 1948 may be configuredto retain the needle 1904 at least partially within the applicatorhousing 1922 following insertion of the transcutaneous analyte sensor 24into the individual's skin and removal of the applicator housing 1922from the transcutaneous analyte sensor 24, and configured to release theneedle 1904 from within the applicator housing 1922 following insertionof the transcutaneous analyte sensor 24 into the individual's skin.

The operation of the applicator 1902 may be illustrated in FIGS.163-166. Referring to FIG. 163, the cartridge 1900 may be inserted intothe receiver 1932 of the applicator housing 1922. The cartridge 1900 maybe coupled to the applicator housing 1922 by being inserted into thereceiver 1932. The cartridge 1900 may be inserted into the side of theapplicator housing 1922, through the side opening 1930 of the applicatorhousing 1922. The rails 1918 may slide along the channels 1920 of theapplicator housing 1922.

As the cartridge 1900 is slid laterally into the applicator housing1922, the cocking surface 1910 of the cartridge 1900 may contact asurface of the insertion actuator carriage 1912 to compress the drivers1914, 1916 and raise the carriage 1912 to the position shown in FIG.163. Further, the carriage 1924 of the retraction actuator may be raisedsuch that the releasable coupler 1944 of the retraction actuator couplesto the coupling member of the insertion actuator carriage 1912. Thecarriages 1912, 1924 of the insertion actuator and retraction actuatormay be in the position shown in FIG. 163. The insertion of the cartridge1900 and the transcutaneous analyte sensor 24 into the receiver 1932through the side opening of the applicator housing 1922 may compress andthus provide energy to both the driver 1914 of the insertion actuatorand the driver 1916 of the retraction actuator. Both drivers 1914, 1916are shown to be compressed in FIG. 163. In an embodiment in which thedrivers 1914, 1916 are springs, the springs may be compressed by theinsertion of the cartridge 1900 and the transcutaneous analyte sensor 24into the receiver. The cocking surface 1910 may comprise a pressingsurface to press against the carriage of the insertion actuator toprovide energy to the insertion actuator.

Referring to FIG. 164, the control device 1925 may be pressed to apply apressing force to the releasable coupler 1938 of the insertion actuatorcarriage 1912. The driver 1914 may press the insertion actuator carriage1912 axially downward and may press against the inner cartridge body1906 of the cartridge 1900. The driver 1914 may be configured to drivethe needle 1904 into the individual's skin to insert the transcutaneousanalyte sensor into the individual's skin.

Referring to FIG. 165, the insertion actuator carriage 1912 may bedriven axially downward to insert the needle 1904 and the transcutaneousanalyte sensor 24 into the individual's skin. The insertion actuatorcarriage 1912 may further press the wearable housing 108 against theindividual's skin to deploy a patch 106 or the like to the individual'sskin.

The releasable coupler 1948 may be pressed downward to couple to aneedle hub 1950 of the needle 1904. The releasable coupler 1948 mayinclude arms that are drawn together as the releasable coupler 1948descends, to cause the releasable coupler 1948 to couple to the needlehub 1950. The arms, however, may include openings that allow the needlehub 1950 to be slid out from the arms to release the needle hub 1950.

Further as shown in FIG. 165, the releasable coupler 1944 of theretraction actuator carriage 1924 may contact the coupler release 1946to disengage from the insertion actuator carriage 1912. As shown in FIG.166, the driver 1916 of the retraction actuator may drive the retractionactuator carriage 1924 upwards to retract the needle 1904 from theindividual's skin. The needle 1904 may then be drawn upwards to coupleto the needle retainer 1909 shown in FIG. 161. The retraction actuatoraccordingly may be configured to automatically operate upon the needle1904 inserting the transcutaneous analyte sensor into the individual'sskin.

The applicator housing 1922 may then be lifted upward to leave theon-skin sensor assembly in position. The cartridge 1900, with the needle1904 coupled to the needle retainer 1909, may then be slid back out ofthe receiver 1932 through the opening 1930 in the side wall. The needle1904 may be separated from the applicator housing by separating thecartridge from the applicator housing. The needle hub 1950 may slide outfrom the releasable coupler 1948 to release from the releasable coupler1948. The cartridge 1900 is configured to be withdrawn from the receiver1932 through the side opening 1930 to release the needle 1904 from thereleasable coupler 1948. The cartridge 1900 is configured to retain theneedle after the cartridge 1900 has been separated from the receiver andthe needle has been inserted into the individual's skin.

The applicator 1902 may return to a state as shown in FIG. 161, toreceive another cartridge 1900. The applicator 1902 accordingly maycomprise a reusable applicator for receipt of multiple differentcartridges 1900. The used cartridge 1900 and needle 1904 may bediscarded.

FIGS. 167-173 illustrate an embodiment of an applicator system in whicha cartridge 2000 may be inserted into side of the applicator 2002. FIG.167 illustrates a system for inserting a transcutaneous analyte sensorinto an individual's skin. A view of the cartridge 2000 is shown in FIG.168. The cartridge 2000 may include an inner cartridge body 2004 and anouter cartridge body 2006 extending over the inner housing or innercartridge body 2004. A removable cover 2008 may seal an opening of theouter cartridge body 2006. The opening 2010 may be on a side of theouter cartridge body 2006 as shown in FIG. 169. Referring to FIG. 167,the outer housing or outer cartridge body 2006 may include a grip 2012for an individual to grip to control movement of the cartridge 2004.

An outer surface of the cartridge 2004 may include protrusions in theform of rails 2014 configured to slide along channels 2016 of theapplicator housing 2018 to align the cartridge 2004 with the receiver ofthe applicator housing.

Referring to FIG. 169, the cartridge 2000 may retain the needle 2019(marked in FIG. 172), the transcutaneous analyte sensor 24, and thewearable housing 108 of the on-skin sensor assembly. The inner cartridgebody 2004 may retain the needle 2019, the transcutaneous analyte sensor24, and the housing of the on-skin sensor assembly.

The inner cartridge body 2004 may further include a needle retainer thatmay be configured similarly as the needle retainer 1909 shown in FIG.161, for retaining the needle 2019 after the needle 2019 has beeninserted into the individual's skin.

The inner cartridge body 2004 may further include a slot 2020 for theelectronics unit 26 to be inserted into, to couple to the wearablehousing 108 while the wearable housing 108 remains coupled to the innercartridge body 2004. The inner cartridge body 2004 may further include areceiver 2022 for receiving a portion of an insertion actuator carriage2025 (marked in FIG. 170).

Referring back to FIG. 167, the applicator 2002 may include theapplicator housing 2018, which may contain the contents of theapplicator 2002 therein. The applicator housing 2018 may be configuredto be gripped to apply the transcutaneous analyte sensor into theindividual's skin. The applicator housing 2018 may include a sideportion (formed by one or more side surfaces 2032 of the applicatorhousing), a top portion (formed by a top surface 2030) and a bottomportion including a bottom opening 2024 for the transcutaneous analytesensor to be deployed from to be inserted into the individual's skin.The opening 2024 may be configured for the needle 2019 and thetranscutaneous analyte sensor 24 to pass through to insert thetranscutaneous analyte sensor 24 into the individual's skin. Thetranscutaneous analyte sensor 24 and needle 2019 may be inserted intothe individual's body from the bottom opening 2024.

The applicator housing 2018 may include a side opening 2026 defining anentry to a receiver 2028 (marked in FIG. 170) of the applicator housing2018 for receiving the cartridge 2000. The receiver 2028 may beconfigured for the cartridge 2000 retaining the transcutaneous analytesensor to be inserted into. The receiver 2028 may include a cavity forreceiving the cartridge 2000 retaining the transcutaneous analytesensor. The side opening 2026 may be positioned transverse to the axialdimension defined by the bottom opening 2024.

The applicator 2002 may include an insertion actuator, which may includea carriage 2033 and a driver 2034 (shown as a spring in FIG. 172). Thecarriage 2033 may be configured to slide relative to the applicatorhousing and be configured to be slid by the driver 2034. The insertionactuator may further include a control device 2036 for activating theinsertion actuator. The insertion actuator may be coupled to theapplicator housing 2018 and may be configured to insert a needle intothe individual's skin to insert a transcutaneous analyte sensor into theindividual's skin. The insertion actuator may be configured to insertthe needle 2019 into the individual's skin with the cartridge 2000positioned in the receiver 2028 of the applicator housing and remainingcoupled to the applicator housing. The receiver 2028 may be configuredto release the cartridge 2000 from the applicator housing.

The control device 2036 may comprise a button that may be pressed by anindividual or other body configured to be moved to release the carriage2033. The control device 2036 may include a button surface 2038 and acontrol arm 2041 (marked in FIG. 173) extending from the button surface2038.

The applicator 2002 may include a retraction actuator for retracting theneedle 2019 from the individual's skin following insertion of thetranscutaneous analyte sensor into the individual's skin. The retractionactuator may be configured similarly as the retraction actuator shown inFIG. 163. The retraction actuator accordingly may be configured toautomatically operate upon the needle 2019 inserting the transcutaneousanalyte sensor into the individual's skin.

Further, the carriage 2025 of the insertion actuator may include areleasable coupler 2040 (marked in FIG. 172) that is configured tocouple to a coupling member 2042 of the applicator housing 2018. Thereleasable coupler 2040 may be positioned such that lateral movement ofthe control device 2036 causes the control arm 2041 to press against thereleasable coupler 2040 to release the releasable coupler 2040.

A releasable coupler 2044 (marked in FIG. 172) may be coupled to aportion of the carriage of the retraction actuator. The releasablecoupler 2044 may be configured to couple to the needle 2019. Thereleasable coupler 2044 may be configured such that sliding lateralmovement of the needle 2019 may release the needle 2019 from thereleasable coupler 2044, in a similar manner as discussed in regard tothe releasable coupler 1948. The releasable coupler 2044 may beconfigured to retain the needle 2019 to the applicator housing 2018following insertion of the transcutaneous analyte sensor 24 into theindividual's skin and removal of the applicator housing 2018 from thetranscutaneous analyte sensor 24, and configured to release the needle2019 from within the applicator housing 2018 following insertion of thetranscutaneous analyte sensor 24 into the individual's skin.

Referring to FIG. 171, the insertion actuator carriage 2025 may becoupled to a cocking device 2046. The cocking device 2046 may comprise alever or other form of cocking device that may be manually pressed orotherwise manually operated. The cocking device 2046 may be configuredto be manually operated to cock the insertion actuator and to provideenergy to the actuator which may include providing energy to the driver2034. The cocking device 2046 may compress the spring in an embodimentin which the driver 2034 is a spring. The cocking device 2046 may becoupled to the carriage 2025 of the insertion actuator and the cockingdevice 2046 may be configured to lift or otherwise move the carriage2025 to compress the driver 2034. As shown in FIG. 171, the cockingdevice 2046 may extend along a slot on the side surface of theapplicator housing 2018 and may protrude and extend outward from theapplicator housing 2018.

The cocking device 2046 may be in an initial uncocked state as shown inFIG. 171 and may be manually moved to a cocked state as shown in FIG.172 in which the cocking device 2046 cocks the actuator. The controldevice 2036 may be configured such that operation of the control device2036 returns the cocking device 2046 to an uncocked state.

The operation of the applicator 2002 may be illustrated in FIGS.169-173. Referring to FIG. 169, the cartridge 2000 may have theremovable cover 2008 removed, and the electronics unit 26 may beinserted into the slot 2020 to couple with the wearable housing 108. Thecartridge may then be inserted into the receiver 2028 of the applicatorhousing 2018 as shown in FIG. 170, with the rails 2014 of the cartridge2000 sliding along the channels 2016 of the applicator housing 2018. Theinsertion actuator carriage 2025 may insert into the receiver 2022 ofthe inner cartridge body 2004. The cartridge 2000 may be coupled to theapplicator housing 2018 by being inserted into the receiver 2028.

Referring to FIG. 171, with the cartridge 2000 positioned within thereceiver 2028 of the applicator housing 2018, the cocking device 2046may be manually moved to cock the insertion actuator. The insertionactuator may be manually cocked. Such cocking action may includecompressing the driver 2034, and coupling the releasable coupler 2040 tothe coupling member 2042 of the applicator housing 2018 as shown in FIG.172. Further, such cocking action may compress a spring of a retractionactuator or otherwise provide energy to a driver of the retractionactuator, with the retraction actuator configured to retract the needlefrom the individual's skin.

Referring to FIG. 172, upon insertion of the cartridge 2000 into thereceiver 2028, the releasable coupler 2044 may be coupled to the needle2019 in a similar manner as shown in FIG. 164. An angled pressingsurface 2048 within the inner cartridge body 2004 may press thereleasable coupler 2044 downward upon the cartridge 2000 being insertedinto the receiver 2028, to cause the releasable coupler 2044 to coupleto the needle 2019.

The outer cartridge body 2006 is configured to be separated from theinner cartridge body 2004 prior to the actuator inserting the needle2019 into the individual's skin. The outer cartridge body 2006 may beremoved from the inner cartridge body 2004 and the receiver 2028 bybeing slid out of the receiver 2028 in an opposite direction from whichthe body 2006 was inserted. With the outer cartridge body 2006 removed,the needle 2019 and the on-skin applicator assembly is exposed to thebottom opening 2024 of the applicator housing 2018 for deployment to theindividual's skin.

The control device 2036 may be activated by the individual to activatethe insertion actuator. Referring to FIG. 173, the driver 2034 of theinsertion actuator may drive the insertion actuator carriage 2025downward to insert the needle 2019 and the transcutaneous analyte sensor24 into the individual's skin. The driver 2034 may be configured todrive the needle 2019 into the individual's skin to insert thetranscutaneous analyte sensor into the individual's skin with thecartridge remaining coupled to the applicator housing. An individual mayleave the cartridge in the receiver of the applicator housing duringsuch operation.

The retraction actuator, which may be configured similarly as theretraction actuator discussed in regard to the applicator 1902, mayretract the needle 2019 from the individual's skin. The needle 2019 mayremain coupled to the releasable coupler 2044 upon withdrawal of theapplicator 2002 from the on-skin sensor assembly.

In a similar manner as discussed in regard to FIG. 166, the innercartridge body 2004 may be removed from the receiver 2028 to withdrawthe used needle 2019 from the applicator housing 2018. For instance, aneedle hub of the needle 2019 may slide out from the releasable coupler2044 to release from the releasable coupler 2044. The cartridge 2004 isconfigured to be withdrawn from the receiver 2028 through the sideopening 2026 to release the needle 2019 from the releasable coupler2044. The needle 2019 may be separated from the applicator housing byseparating the cartridge 2004 from the applicator housing.

The cartridge 2000 is configured to retain the needle after thecartridge 2000 has been separated from the receiver and the needle hasbeen inserted into the individual's skin.

The applicator 2002 may return to a state as shown in FIG. 170, toreceive another cartridge 2000. The applicator 2002 accordingly maycomprise a reusable applicator for receipt of multiple differentcartridges 2000. The used cartridge 2000 and needle 2019 may bediscarded.

In embodiments disclosed herein, the electronics unit 26 may be coupledto the wearable housing 108 of the on-skin sensor assembly either priorto deployment of the on-skin sensor assembly to the individual's skin orafter deployment to the individual's skin. A variety of methods may beutilized to couple the electronics unit 26 to the wearable housing 108.FIGS. 174-187 illustrate methods that may be utilized.

FIG. 174 illustrates an embodiment of a wearable assembly 2100 in whichthe electronics unit 26 includes a coupler in the form of a clip 2102 atan end of the electronics unit 26. The wearable housing 108 of thewearable assembly 2100 includes a coupling member in the form of a post2104 for coupling to the clip 2102. The electronics unit 26, with theclip 2102 coupled to the post 2104 may be configured to rotate about thepost 2104 to have an opposite end of the electronics unit 26 couple to alatch 2106. Each of the couplers may be releasable as desired to allowthe electronics unit 26 to be released from the wearable housing 108.

FIG. 175 illustrates an embodiment of a wearable assembly 2200 in whichthe electronics unit 26 includes a coupler in the form of a magnet 2202and an opening 2204 at an end of the electronics unit 26. The wearablehousing 108 of the wearable assembly 2200 includes a coupling member inthe form of a magnet 2206 and a post 2208 for coupling to the magnet2202 and opening 2204 respectively. The electronics unit 26, with theopening 2204 coupled to the post 2208 may be configured to rotate aboutthe post 2208 to have an opposite end of the electronics unit 26 coupleto a coupler in the form of a latch 2210. Each of the couplers may bereleasable as desired to allow the electronics unit 26 to be releasedfrom the wearable housing 108.

FIG. 176 illustrates an embodiment of a wearable assembly 2300 in whichthe electronics unit 26 includes a coupler in the form of a magnet 2302surrounding an opening 2304 at an end of the electronics unit 26. Thewearable housing 108 of the wearable assembly 2300 includes a couplingmember in the form of a magnet 2306 surrounding a post 2308 for couplingto the magnet 2302 and opening 2304 respectively. The electronics unit26, with the opening 2304 coupled to the post 2308 may be configured torotate about the post 2308 to have an opposite end of the electronicsunit 26 couple to a coupler in the form of a latch 2310. Each of thecouplers may be releasable as desired to allow the electronics unit 26to be released from the wearable housing 108.

FIG. 177 illustrates an embodiment of a wearable assembly 2400 in whichthe electronics unit 26 includes a coupler in the form of an opening2402 at an end of the electronics unit 26. The wearable housing 108 ofthe wearable assembly 2400 includes a coupling member in the form of apost 2404 for coupling to opening 2402. The electronics unit 26, withthe opening 2402 coupled to the post 2404 may be configured to rotateabout the post 2404 to have an opposite end of the electronics unit 26couple to a coupler in the form of a latch 2406. Each of the couplersmay be releasable as desired to allow the electronics unit 26 to bereleased from the wearable housing 108.

FIG. 178 illustrates an embodiment of a wearable assembly 2500 in whichthe electronics unit 26 includes a coupler in the form of a magnet at acentral location in the electronics unit 26. The wearable housing 108 ofthe wearable assembly 2500 includes a coupling member in the form of amagnet 2502 for coupling to the magnet of the electronics unit 26. Theelectronics unit 26, may be configured to slide upon the wearablehousing 108 to have the electronics unit 26 couple to a coupler in theform of a latch 2504. The electronics unit 26 may slide until contactinga wall 2506 of the wearable housing 108. Each of the couplers may bereleasable as desired to allow the electronics unit 26 to be releasedfrom the wearable housing 108.

FIG. 179 illustrates an embodiment of a wearable assembly 2600 in whichthe electronics unit 26 includes a coupler in the form of an opening2602 magnet at an end of the electronics unit 26. The wearable housing108 of the wearable assembly 2600 includes a coupling member in the formof a tapered pin 2604 for coupling to the opening 2602 of theelectronics unit 26. The electronics unit 26, may be configured torotate upon the wearable housing 108 to have an opposite end of theelectronics unit 26 couple to a coupler in the form of a latch 2606.Each of the couplers may be releasable as desired to allow theelectronics unit 26 to be released from the wearable housing 108.

FIG. 180 illustrates an embodiment of a wearable assembly 2700 in whichthe electronics unit 26 includes a coupler in the form of an opening2702 and a magnet 2704 at an end of the electronics unit 26. Thewearable housing 108 of the wearable assembly 2700 includes a couplingmember in the form of a magnet 2706 and a post 2708 for coupling to themagnet 2704 and opening 2702 of the electronics unit 26. The electronicsunit 26, may be configured to rotate upon the wearable housing 108 tohave an opposite end of the electronics unit 26 couple to a coupler inthe form of a latch 2710. The latch 2710 may be a releasable latch 2710,operable by pressing the lever 2712. Each of the couplers may bereleasable as desired to allow the electronics unit 26 to be releasedfrom the wearable housing 108.

FIG. 181 illustrates an embodiment of a wearable assembly 2800 in whichthe electronics unit 26 includes a coupler in the form of an opening2802 at an end of the electronics unit 26. The wearable housing 108 ofthe wearable assembly 2800 includes a coupling member in the form of apost 2804 for coupling to the opening 2802 of the electronics unit 26.The electronics unit 26, may be configured to rotate upon the wearablehousing 108 to have an opposite end of the electronics unit 26 couple toa coupler in the form of a latch 2806. The latch 2806 may be areleasable latch 2806, operable by pressing a lever that is similar tolever 2712. Each of the couplers may be releasable as desired to allowthe electronics unit 26 to be released from the wearable housing 108.

FIG. 182 illustrates an embodiment of a wearable assembly 2900 in whichthe electronics unit 26 includes a coupler in the form of a plurality ofmagnets 2902, 2904 in a central portion of the electronics unit 26. Thewearable housing 108 of the wearable assembly 2900 may include acoupling member in the form of magnets of correspondingly oppositepolarity for coupling with the magnets 2902, 2904. The electronics unit26 may be configured lock to the wearable housing 108 by way of acoupler in the form of a lock arm 2906 that pivots to cover a portion ofthe electronics unit 26. Each of the couplers may be releasable asdesired to allow the electronics unit 26 to be released from thewearable housing 108.

FIG. 183 illustrates an embodiment of a wearable assembly 3000 in whichthe electronics unit 26 includes a coupler in the form of a magnet 3002in a central portion of the electronics unit 26. The wearable housing108 of the wearable assembly 3000 may include a coupling member in theform of a magnet of correspondingly opposite polarity for coupling withthe magnet 3002. The electronics unit 26 may be configured lock to thewearable housing 108 by way of a coupler in the form of two lips 3004,3006 that extend over a portion of the wearable housing 108 as thewearable housing 108 rotates to couple to the electronics unit 26. Eachof the couplers may be releasable as desired to allow the electronicsunit 26 to be released from the housing 108.

FIG. 184 illustrates an embodiment of a wearable assembly 3100 in whichthe electronics unit 26 includes a coupler in the form of a magnet 3102in a central portion of the electronics unit 26. The wearable housing108 of the wearable assembly 3100 may include a coupling member in theform of a magnet of correspondingly opposite polarity for coupling withthe magnet 3102. The electronics unit 26 may be configured lock to thewearable housing 108 by way of a coupler in the form of a lips 3104 thatextend over a portion of the wearable housing 108 as the electronicsunit 26 slides to couple to the electronics unit 26. Each of thecouplers may be releasable as desired to allow the electronics unit 26to be released from the wearable housing 108.

FIG. 185 illustrates an embodiment of a wearable assembly 3200 in whichthe electronics unit 26 includes a coupler in the form of a plurality ofmagnets 3202, 3204 at ends of the electronics unit 26. The wearablehousing 108 of the wearable assembly 3200 may include a coupling memberin the form of a plurality of magnets of correspondingly oppositepolarity for coupling with the magnets 3202, 3204 and for aligning theelectronics unit 26 in the desired orientation on the wearable housing108. The electronics unit 26 may be configured to lock to the wearablehousing 108 by way of a coupler in the form of a rail, which as shown inFIGS. 186 and 187 may include a dove tail shaped rail 3206 a and at-slot shaped rail 3206 b, inserted into correspondingly shaped channelsin the electronic unit 26. Each of the couplers may be releasable asdesired to allow the electronics unit 26 to be released from thewearable housing 108.

FIG. 188 illustrates an embodiment of a cartridge 3300 having a body3302 configured to be coupled to an applicator housing of atranscutaneous analyte sensor applicator. The body 3302 may include abottom cavity 3304 marked in FIG. 189 that is configured to receiveanother body 3306 (marked in FIG. 190) that has a same shape as the body3302 to stack the body 3302 upon the body 3306.

The cartridge 3300 may include a cover 3308 comprising a lid or seal ofthe body 3302. The cover 3308 may cover an upper opening 3310 of thebody 3302 and cover the contents of the upper cavity 3312 (marked inFIG. 189) of the body 3302 retaining the transcutaneous analyte sensor,the needle configured to insert the transcutaneous analyte sensor intothe skin of an individual, and may include a wearable housing and patchas disclosed herein.

Referring to FIG. 189, the body 3302 may have a bottom surface 3314 thatis wider than an upper surface 3316 of the body 3302. The body 3302 mayhave a trapezoidal shape in embodiments, or may have another shape asdesired. The bottom cavity 3304 may be shaped to receive anothercartridge, which may be similarly shaped as the cartridge 3300. Forexample, referring to FIG. 190, the cartridge 3300 may stack upon theother cartridge 3307, with the body 3306 of the other cartridge 3307fitting into the bottom cavity 3304. Thus, space saving may be realized,as the cartridges 3300, 3307 may be stacked to reduce the total size ofthe combination. Multiple other cartridges may be stacked as well.

Any embodiment of cartridge disclosed herein may comprise a stackablecartridge as desired.

FIG. 191 illustrates an embodiment of a kit or system 3400 that may beutilized for storage or transport of a transcutaneous analyte sensorapplicator and cartridges according to embodiments herein. A case 3402may be utilized including an area 3404 for receiving an applicatorhousing 3406, which may comprise any form of applicator housing asdisclosed herein. The area 3404 may comprise a cavity or other receivingarea in embodiments. The case 3402 may include an area 3408 forreceiving another component of the applicator system, such as a sharpscontainer 3410 for retaining used needles. The sharps container 3410 maycomprise a convenient receptacle for used needles. In embodiments, acover 3412 may be provided for the case 3402.

Other components may be stored, including cartridges 3414 that may beutilized with the applicator housing 3406. The cartridges 3414 inembodiments may be stackable, as disclosed herein and/or may beconfigured to fit into a case 3416 for the cartridges 3414. The case3416 may include areas 3418 for receiving the cartridges 3414. Inembodiments, a single case may be provided for all components.

FIGS. 192-195 illustrate embodiments of covers for cartridges that maybe utilized in embodiments herein. FIG. 192, for example, illustrates acontainer 3500 for a cartridge 3502, in which the container 3500includes a removable cover 3504 or lid. The cover 3504 may be removed toaccess the cartridge 3502 within the container 3500.

FIG. 193, for example illustrates a cartridge 3510 having a cover 3512with two sides connected. An upper cover 3514 may cover an upper openingof the cartridge 3510 and a lower cover 3516 may cover a lower openingof the cartridge 3510. A connecting portion 3518 may couple the uppercover 3515 to the lower cover 3516 such that removal of one of thecovers 3514, 3516 removes both covers 3514, 3516 at the same time. Thus,an ease of use and time saving may be realized.

FIGS. 194-195 illustrate an embodiment of a cartridge 3520 including acover 3522 in the form of a puncturable layer. The cartridge 3520 may beinserted into a receiver of an applicator housing and the cover 3522 maybe punctured upon insertion. As such, no cover 3522 is manually removedby the individual. Rather, the cover 3522 is automatically puncturedupon insertion into a receiver.

The embodiments of covers may be utilized with any embodiment ofcartridge herein.

FIG. 196 illustrates an embodiment of an applicator 3600 that may beutilized according to embodiments of applicators herein. A cover 3602may be provided for the bottom surface of the applicator 3600 thatcovers the bottom opening of the applicator 3600. As such, access to thereceiver of the applicator 3600 may be blocked in embodiments. For use,the cover 3602 may be removed by an individual.

Any embodiment of applicator disclosed herein may utilize a cover over aportion of the applicator.

FIG. 197 illustrates an embodiment of an applicator 3700 and anembodiment of a cartridge 3702 that may be utilized according toembodiments herein. The applicator 3700 may include a tactile indictor3704 on an outer surface of the applicator 3700 that may be configuredto indicate a position of a feature or component of the applicator 3700.The tactile indicator 3704, for example, may indicate a position of acontrol device 3706 that may be operated to perform a function of theapplicator 3700, for example, an insertion or release operation of theapplicator 3700, among others. The tactile indicator 3704 may allow theuser to feel the indicator 3704 to determine the location of the featureor component of the applicator 3700, such as a control device 3706. Thetactile indicator 3704 may have a variety of forms, for example, thetactile indicator 3704 may comprise a roughened outer surface of theapplicator housing as shown in FIG. 197. The roughened outer surface mayindicate a position of the control device 3706. The tactile indicator3704 may have other forms such as a slick portion of the applicatorhousing, or a series of raised characters on the applicator housing,among other forms.

The cartridge 3702 may include a tactile indicator 3708 that may have asimilar configuration as the tactile indicator 3704 of the applicator3700, or may have a different configuration. The tactile indicator 3708may be positioned on an outer surface of the cartridge 3702 and mayindicate a feature or component of the cartridge, such as a keyedportion of the cartridge used to align with a receiver of the applicator(a keyed portion of a cartridge being shown in FIG. 198 for example).

The tactile indicator 3708 may indicate other features or components ofthe cartridge 3702 as desired, and may be felt by a user to determinethe location of such features or components. The tactile indicator 3708may have a variety of forms, for example, the tactile indicator 3708 maycomprise a roughened outer surface of the cartridge as shown in FIG.197, or may have other forms as discussed in regard to the applicator3700, for example. Any embodiment of applicator or cartridge, or otherfeature of a system, disclosed herein may include a tactile indicator.

FIGS. 198-214 illustrates a variation of the embodiments of FIGS.93-106. In the embodiments of FIGS. 198-214, a release actuator may beutilized in the applicator system. Other modifications of theembodiments of FIGS. 93-106 may be provided.

FIG. 198 illustrates an assembly view of a cartridge 3800 that may beutilized. The cartridge 3800 may be configured similarly as othercartridges disclosed herein, and may include a body 3802 having a base3804 and a wall 3806 surrounding a cavity 3808 for receiving the on-skinsensor assembly 3810. The cartridge 3800 may be configured to beinserted into an applicator housing and may retain a transcutaneousanalyte sensor. The cartridge 3800 may include a body configured to becoupled to an applicator housing and may include a retainer retainingthe transcutaneous analyte sensor and a wall extending around at least aportion of the transcutaneous analyte sensor.

The cartridge 3800 may include one or more coupling members in the formof coupling surfaces 3812 that may be configured to couple to one ormore coupling members 3814 of the needle hub 3816. The coupling surfaces3812, for example, may engage the coupling members 3814 of the needlehub 3816 by forming a ledge that the coupling members 3814 arepositioned under.

The cartridge 3800 may include a keyed portion 3818, similar to otherembodiments of cartridges disclosed herein. The keyed portion 3818 maybe configured to align the cartridge 3800 with a receiver of theapplicator housing in a single rotational orientation. For example, thekeyed portion 3818 may comprise one or more of a protrusion 3820 or aflattened portion 3822 that may be utilized to align with acorresponding shape of a receiver. The use of the keyed portion 3818 mayreduce the possibility of misinsertion of the cartridge into thereceiver of the applicator housing. Any embodiment of cartridge 3800disclosed herein may include a keyed portion.

The needle hub 3816 may include multiple components including a needlecover 3824 and a rotating body 3826. The rotating body 3826 may coupleto the proximal portion of the needle 3828 and may couple to the needlecover 3824 at the proximal portion of the needle 3828. The rotating body3826 may include a pivot 3830 that couples to the needle cover 3824 andallows the rotating body 3826 to rotate with respect to the needle cover3824. The rotating body 3826 may include a locking surface 3832 that isconfigured to engage a lock 3834 (marked in FIG. 212) of the needlecover 3824 upon rotation of the rotating body 3826 and the needle 3828relative to the needle cover 3824. The lock 3834 may lock the needle3828 in position within the needle cover 3824.

The needle cover 3824 may be configured to rotate relative to the needle3828 to extend over at least the portion of the needle 3828. The needle3828 is configured to be moved relative to the needle cover 3824 to bepositioned into the needle cover 3824. The needle cover 3824 may includea channel 3836 (marked in FIG. 212) that is configured to receive theneedle 3828 upon the needle 3828 rotating into the needle cover 3824.The channel 3836 may extend along the length of the body of the needlecover 3824. Further, the needle cover 3824 may include a channel 3838that is configured for a deflection surface 3840 (marked in FIG. 210) topass through to rotate the needle 3828. The channel 3838 may extendvertically or transverse with respect to the horizontal length of theneedle cover 3824. The channel 3838 for the deflection surface 3840 mayextend perpendicular with respect to the needle channel 3836. Aninsertion carriage 3900 shown in FIG. 203 may include the deflectionsurface 3840 that may be utilized to deflect the rotating body 3826 uponretraction of the needle 3828.

The needle cover 3824 may be configured to extend along the plane of thepatch 3842 and along the plane of the wearable housing 3844 whenpositioned within the cartridge 3800. The length of the needle cover3824 may extend along the plane of the opening 3847 (marked in FIG. 204)of the applicator housing. The needle 3828 may be configured to extendat an angle, transverse and perpendicular, with respect to the needlecover 3824 when positioned within the cartridge 3800. The needle 3828,for example, may extend within a cavity 3846 (marked in FIG. 198) of thecartridge 3800 for receiving the needle 3828.

The needle cover 3824 may include opposite ends having coupling members3814. Each of the coupling member 3814 may be configured to engage thecoupling surfaces 3812 of the cartridge 3800 to retain the needle cover3824 and the on-skin sensor assembly 3810 within the cartridge 3800prior to insertion of the cartridge 3800 into the applicator housing.The coupling members 3814 may comprise deflectable arms configured todeflect inward with respect to the needle cover 3824 to allow thecoupling members 3814 to disengage from the coupling surfaces 3812 ofthe cartridge 3800. Each of the coupling members 3814 may be biased todeflect outward with respect to the needle cover 3824 to retainengagement between the coupling member 3814 and the coupling surfaces3812 of the cartridge 3800. Each of the coupling members 3814 mayinclude one or more protrusions 3849 that may be configured to engage areleasable coupler of an applicator.

A pull tab 3848 may be positioned within the cartridge 3800 and may beconfigured to couple to the needle hub 3816 of the needle 3828. The pulltab 3848 may be configured to be pulled to release the needle 3828 fromthe releasable couplers 3890, 3892 shown in FIG. 203.

The pull tab 3848 may have a ring configuration and may be configured toextend circumferentially about the wearable housing 3844 of the on-skinsensor assembly 3810. The pull tab 3848 may be positioned upon the patch3842, although other locations may be provided in embodiments. The pulltab 3848 may have a folded configuration, with a first portion 3850folded upon a second portion 3852 to form a crescent shape as shown inFIG. 198. The pull tab 3848 may be configured to unfold at a desiredtime to form a ring for grasping by a user. The pull tab 3848 mayinclude a coupling portion 3845 for a screw 3851 or other form ofcoupler to pass through, for the pull tab 3848 to couple to the needlehub 3816.

FIG. 199 illustrates the on-skin sensor assembly 3810 positioned withinthe cartridge 3800. The coupling members 3814 of the needle cover 3824engage the coupling surfaces 3812 of the cartridge 3800. The pull tab3848 is in a folded configuration positioned circumferentially about theapplicator housing 3844.

Referring to FIG. 200, in embodiments, the needle hub and needle covermay include one or more releasable couplers 3854 that may be configuredto engage the wearable housing 3844 to retain the wearable housing 3844to the needle hub 3816. FIG. 200, for example, illustrates aconfiguration of a needle hub 3856 including such releasable couplers3854. In embodiments, the releasable couplers 3854 may be included orexcluded as desired.

FIG. 200 illustrates an embodiment of a pull tab 3858 that may beconfigured similarly as the pull tab 3848 yet including a loopedcoupling portion 3861 that may be configured to hook onto a coupler 3859of the needle hub 3856. FIG. 201 illustrates the coupling of the pulltab 3858 to the needle hub 3856. FIG. 202 illustrates an assembly stepin which the pull tab 3858 may be folded to form a crescent shape. Thefirst portion 3860 may be folded upon the second portion 3862 with thefirst portion 3860 and second portion 3862 positioned on opposite sidesof the coupling member 3814. The rotating body 3826 of the needle hub3856 may be inserted into the needle cover 3824, with the pivot 3830inserting into the aperture 3863 shown in FIG. 202. The needle hub 3856coupled to the pull tab 3858 may be inserted into the cartridge 3800over the wearable housing 3844 of the on-skin sensor assembly 3810, in aconfiguration shown in FIG. 199, for example.

In embodiments, a cover may be positioned over the upper opening 3864(marked in FIG. 199) of the cartridge 3800 to seal the contents of thecartridge, similar to other embodiments of cartridges disclosed herein.

FIG. 203 illustrates components of an applicator 3870 that may beutilized. The applicator 3870 may include an applicator housing 3872that may have an outer housing 3874 and an interior housing 3876. Theapplicator housing 3872 may be configured to be gripped by an individualto apply the transcutaneous analyte sensor into the individual's skin.The applicator housing may include a side portion, a top portion and abottom portion including an opening 3847 (marked in FIG. 204) for thetranscutaneous analyte sensor to be deployed from to be inserted intothe individual's skin. The receiver of the applicator housing may beconfigured to receive the cartridge 3800 through the opening of thebottom portion.

The outer housing 3874 may comprise an outer surface of the applicator3870, and may include a control device 3878 that may be activated tocause the transcutaneous analyte sensor of the on-skin sensor assembly3810 to be inserted into the individual's skin. The control device 3878may be operated by an individual. For example, the control device 3878may comprise a button that is pressed to activate an insertion actuatorof the applicator 3870.

The interior housing 3876 may be positioned within the outer housing3874 and may include a central cavity 3880 (marked in FIG. 204) forcomponents of the applicator 3870 to be positioned within. The interiorhousing 3876 may include an outer surface 3881 including an aperture3882 for a releasable coupler 3884 to pass through, to hold theassemblies in position relative to the interior housing 3876. Theinterior housing 3876 may further include an upper surface 3883configured for biasing members 3886 in the form of springs, andparticularly coil springs configured to bias the interior housing 3876downward with respect to the outer housing 3874 of the applicator. Theinterior housing 3876 may include the lower opening 3847 at a bottomsurface of the interior housing 3876 for the transcutaneous analytesensor, and the needle 3828 and wearable housing 3844 to be deployedfrom.

FIG. 203 illustrates a perspective view of a first carriage 3888 thatmay comprise a retraction carriage for retracting the needle 3828 fromthe individual's skin following insertion of the needle 3828. Thecarriage 3888 may include releasable couplers 3890, 3892 that engage theneedle hub of the needle, to withdraw the needle from the individual'sskin following insertion into the individual's skin. The releasablecouplers 3890, 3892, for example, may be configured to engage theprotrusions 3849 of the coupling members 3814 shown in FIGS. 198 and 200to couple to the needle hub and the needle.

One or more of the releasable couplers 3890, 3892 may be configured toretain a needle to the applicator housing following insertion of thetranscutaneous analyte sensor into the individual's skin and removal ofthe applicator housing from the transcutaneous analyte sensor, andrelease the needle from within the applicator housing followinginsertion of the transcutaneous analyte sensor into the individual'sskin. The one or more releasable couplers 3890, 3892 may be configuredto couple to the needle hub of the needle.

The releasable coupler 3890 may be a static or non-rotating releasablecoupler 3890 and the releasable coupler 3892 may be configured to rotateto couple or uncouple from the needle hub. The releasable coupler 3892may be configured to rotate to hook onto or release from the needle hubof the needle. The releasable coupler 3892, for example, may bepivotally coupled to the carriage 3888. The releasable coupler 3892 mayinclude one or more hooks 3894 for coupling to the needle hub and mayinclude one or more deflection surfaces 3896 configured to be contactedto rotate the releasable coupler 3892 into a desired position. Theinsertion carriage may include a guide channel 3898 (marked in FIG. 210)that the deflection surface 3896 slides along to deflect the deflectionsurface 3896 and rotate the releasable coupler 3892 into a desiredposition.

The guide channel 3898 and deflection surfaces 3896 may comprise arelease actuator configured to release the needle and the needle cover3824 from the releasable coupler 3892. The release actuator may releasethe needle from the releasable coupler 3892 to allow the needle to bepassed through the opening 3847 marked in FIG. 204. The release actuatormay be configured to release the needle covered by the needle cover 3824from the applicator housing following insertion of the needle into theindividual's skin.

Referring to FIG. 203, the first carriage 3888 may further includecoupler releases in the form of deflectors 3899 configured to release acoupler to allow the first carriage 3888 to move relative to theinsertion carriage 3900. The deflectors 3899, for example, may beconfigured to deflect the releasable couplers 3902 of the insertioncarriage 3900 shown in FIG. 204 to release the carriages 3888, 3900 fromeach other. The releasable couplers 3902 may release to allow the driver3918 to move the carriages 3888, 3900 away from each other. Thereleasable couplers 3902 may be configured to resist the force of thedriver 3918. The releasable couplers 3902 may be configured toautomatically release upon contact with the coupler release. The firstcarriage 3888 may further include protrusions 3904 that retain the firstcarriage 3888 to the second carriage 3910.

The second carriage 3910 may include support surfaces 3912 for theprotrusions 3904 to contact to keep the carriages 3888, 3910 engagedwith each other. The second carriage 3910 may further include supportsurfaces 3914 for the releasable couplers 3902 shown in FIG. 204 toengage with. The second carriage 3910 may further include a centralchannel 3915 for the first carriage 3888 to be positioned within.

The insertion carriage 3900 may include the releasable couplers 3902 forengaging with the support surface 3914 of the second carriage 3910. Theinsertion carriage 3900 may comprise a component of an actuator orinsertion actuator that may be coupled to the applicator housing andconfigured to insert a needle and the transcutaneous analyte sensor intothe individual's skin. The insertion carriage 3900 may be configured toslide relative to the applicator housing and configured to be slid bythe driver 3916.

The insertion carriage 3900 may further include a releasable coupler3884 for engaging with the interior housing 3876 of the applicator, andparticularly with an aperture 3882 of the interior housing 3876. Theinsertion carriage 3900 may include a central channel 3919 (marked inFIG. 204) for the carriages 3888, 3910 to be positioned within.

The applicator 3870 may further include a driver 3916 in the form ofsprings configured to drive the entire assembly of carriages, includingthe insertion carriage 3900 downward to drive the needle into theindividual's skin to insert the transcutaneous analyte sensor into theindividual's skin. The applicator 3870 may further include a driver 3918in the form of springs configured to retract the carriages 3888, 3910 toretract the needle from the individual's skin following deployment. Theapplicator 3870 may further include a spring 3920 that biases the firstcarriage 3888 away from the second carriage 3910.

In assembly, the first carriage 3888 may be positioned within thechannel 3915 of the second carriage 3910, and the carriages 3888, 3910may be positioned within the central channel 3919 of the insertioncarriage 3900. The assembly may be positioned within the interiorhousing 3876 shown in FIG. 204.

FIG. 204 illustrates a three-quarters cross sectional perspective viewof the applicator 3870, including carriages 3900, 3888, 3910 assembledand positioned within the interior housing 3876. The interior housing3876 may be positioned within the outer housing 3874 and may beconfigured to slide within the outer housing 3874. The biasing members3886 (marked in FIG. 203), for example, may press against the interiorsurface of the top of the outer housing 3874 to bias the interiorhousing 3876 towards the lower opening 3847. A force applied upwardsagainst the interior housing 3876, by the skin of an individual, forexample, may move the interior housing 3876 upwards within the outerhousing 3874.

FIGS. 204-214 illustrate steps of a method that may utilize theapplicator 3870. Referring to FIG. 204, in the initial configuration,the interior housing 3876 may be biased downward with respect to theouter housing 3874 via the biasing members 3886 shown in FIG. 203.Further, the releasable coupler 3884 may be disengaged with the aperture3882, and the driver 3916 may drive the carriage 3900 to be positioneddownward at this point. The releasable coupler 3902 may not yet beengaged with the support surface 3914 at this point.

The releasable coupler 3892 may be rotated radially outward in theinitial state shown in FIG. 204.

The cartridge 3800 may be inserted into the receiver of the applicator3870. Upon initial insertion, a configuration as shown in FIG. 205 mayresult. The cartridge 3800 may be inserted to contact the insertioncarriage 3900 and drive the insertion carriage 3900 upward. The driver3916 may be compressed. The releasable coupler 3884 may move in adirection to engage the aperture 3882 of the interior housing 3876.

The cartridge 3800 may be inserted into the applicator housing toprovide energy to the insertion actuator and the retraction actuator.The force applied by the cartridge 3800 to the insertion and retractionactuators may provide energy to the insertion and retraction actuators.The insertion of the cartridge 3800 may provide energy to the drivers3916, 3918. In an embodiment in which the drivers 3916, 3918 comprisesprings, the insertion of the cartridge into the receiver may compressthe springs. The cartridge 3800 may include a pressing surface forpressing against the insertion and retraction actuators for providingenergy to the actuators.

The releasable coupler 3892 may be rotated radially inward as shown inFIG. 205, such that the releasable coupler 3892 is oriented axially orvertically within the applicator. Referring to FIG. 210, such movementmay be caused by the guide channel 3898 applying a force to thedeflection surfaces 3896 of the releasable coupler 3892 to orient thereleasable coupler 3892 axially or vertically. The upward movement ofthe insertion carriage 3900 may produce the rotation of the releasablecoupler 3892 via contact between the guide channel 3898 and thedeflection surfaces 3896 of the releasable coupler 3892.

Referring to FIG. 206, the cartridge 3800 may continue to be inserteduntil the releasable couplers 3890, 3892 (shown in FIG. 203) of thefirst carriage 3888 fully engage the coupling members 3814 of the needleand needle hub 3856 (marked in FIG. 200). The coupling members 3814 ofthe needle hub 3856 may deflect inward to allow the releasable couplers3890, 3892 to couple to and hook around the protrusions 3849 of thecoupling members 3814. Further, the inward deflection of the couplingmembers 3814 may decouple the coupling members 3814 from the couplingsurfaces 3812 of the cartridge 3800 shown in FIG. 199. As such, theneedle and needle hub 3856 may be released from the cartridge 3800 andcoupled to the first carriage 3888. The coupling of the releasablecouplers 3854 of the needle hub 3856 (marked in FIG. 200) to thewearable housing 3844 may retain the on-skin sensor assembly 3810 to thecarriage 3888. The cartridge 3800 accordingly may be withdrawn from thereceiver of the applicator 3870 with the on-skin sensor assembly 3810retained by the first carriage 3888 as shown in FIG. 207.

Referring to FIG. 206, the releasable coupler 3884 may fully engage theaperture 3882 of the interior housing 3876. The releasable coupler 3902of the insertion carriage 3900 may engage the support surface 3914 ofthe second carriage 3910 to couple the insertion carriage 3900 to thefirst and second carriages 3888, 3910.

The cartridge 3800 may be removed from the applicator housing prior tothe needle being inserted into the individual's skin to insert thetranscutaneous analyte sensor into the individual's skin.

With the cartridge 3800 withdrawn, the interior housing 3876 may bebiased downward away from the top of the outer housing 3874. In such aconfiguration, the releasable coupler 3884 of the insertion carriage3900 may be offset from the position of the control device 3878, suchthat pressing the control device 3878 does not actuate insertion of theneedle 3828. Such a feature may serve as a safety feature to reduce thepossibility of inadvertent actuation of the needle 3828 prior to adesired time (at which the bottom surface 3922 of the interior housing3876 does not yet contact the individual's skin).

FIG. 207 illustrates a configuration of the applicator 3870 if thebottom surface 3922 of the interior housing 3876 were in contact withthe individual's skin to overcome the bias of the biasing members 3886.In such a configuration, the position of the releasable coupler 3884 maybe moved upwards to align with the control device 3878. As such,movement of the control device 3878 may result in the releasable coupler3884 being pressed to release the insertion carriage 3900 from theinterior housing 3876 and allow the driver 3916 to drive the carriages3900, 3910, 3888 downward.

FIG. 208, for example, illustrates the control device 3878 having beenpressed to release the releasable coupler 3884 from the aperture 3882 ofthe interior housing 3876. The driver 3916 drives the carriages 3900,3910, 3888 downward to press the needle 3828 into the individual's skinto deploy the transcutaneous analyte sensor into the individual's skin.The insertion carriage 3900 may remain coupled to the carriages 3910,3888 by the releasable coupler 3902 remaining coupled to the supportsurfaces 3914.

The carriages 3900, 3910, 3888 may continue to be driven downward untilcontact occurs between the on-skin sensor assembly 3810 and theindividual's skin. FIG. 209, for example, illustrates a positionrepresenting contact between the on-skin sensor assembly 3810 and anindividual's skin. FIG. 210 illustrates a cross sectional view ofcontact between the on-skin sensor assembly 3810 and the individual'sskin.

Referring to FIG. 209, upon contact between the on-skin sensor assembly3810 and the individual's skin, the first carriage 3888 may displacerelative to the second carriage 3910, with the second carriage 3910moving downward relative to the first carriage 3888. The releasablecoupler 3902 may move relative to the first carriage 3888, andparticularly the deflection surfaces 3899 of the first carriage 3888 maypush the releasable coupler 3902 outward away from the support surfaces3914 and off of the support surfaces 3914. The driver 3918 may drive thecarriages 3910, 3888 upward relative to the insertion carriage 3900 andmay pull the needle 3828 upward by way of the coupling of the couplingmember 3814 of the needle hub 3856 with the releasable couplers 3890,3892.

FIG. 211, for example, illustrates the carriages 3910, 3888 beingpressed upward by the driver 3918, and away from the insertion carriage3900.

Referring to FIG. 212, the rotating body 3826 of the needle hub 3856 maybe contacted by the deflection surface 3840 of the insertion carriage3900 to cause the rotating body 3826 to rotate the needle 3828 into theneedle cover 3824. The needle cover 3824 may contact the deflectionsurface 3840, such that the retraction actuator comprising the carriages3888, 3910 and the driver 3918 rotates the needle 3828 into the needlecover 3824. The driver 3918 may drive the needle out of the individual'sskin. The driver 3918 may slide the carriages 3888, 3910 relative to theapplicator housing. The retraction actuator may retract the needle fromthe individual's skin following insertion of the transcutaneous analytesensor into the individual's skin. The retraction actuator may beconfigured to automatically operate upon the needle inserting thetranscutaneous analyte sensor into the individual's skin. The retractionactuator may position the needle 3828 into the needle cover 3824, andmay rotate the needle 3828 into the needle cover 3824.

The lock 3834 may lock the needle 3828 into the needle cover 3824.

The retraction actuator of the applicator 3870 may be configured toactivate based on a force of contact with the individual's skin at adeployment site of the transcutaneous analyte sensor. The retractionactuator of the applicator 3870 may activate at the point of contactwith the individual's skin. For example, if the individual's skinprotrudes into the receiver of the applicator housing then theretraction actuator may activate at the position of the individual'sskin rather than at a defined position relative to the applicator. Thisfeature may be beneficial in a case where skin protrudes greatly intothe receiver of the applicator, to allow for the retraction actuator toactivate due to the force of contact with the individual's skin and thusat the position of the individual's skin.

The retraction actuator may operate based on the insertion carriage 3900over traveling with respect to the first carriage 3888. The insertioncarriage 3900 may displace relative to the first carriage 3888 based oncontact with the individual's skin to operate the release actuator. Thedownward movement of the first carriage 3888 may be impeded by contactwith the individual's skin, thus causing the insertion carriage 3900 tomove downward relative to the first carriage 3888 and displacingrelative to the first carriage 3888. Such displacement may cause therelease of the releasable coupler 3902 and the retraction of the needle3828, due to the release of the releasable couplers 3902.

The rotatable releasable coupler 3892 may be retracted relative to theinsertion carriage 3900 and along the guide channel 3898 to a positionof the guide channel 3898 that allows the rotatable releasable coupler3892 to rotate outward with respect to the coupling member 3814 of theneedle hub 3856. As such, the outward biasing force of the couplingmember 3814 may push the rotatable releasable coupler 3892 outward toallow the releasable coupler 3892 to decouple from and unhook from thecoupling member 3814. The releasable coupler 3892 may release the needle3828 positioned within the needle cover 3824 from within the applicatorhousing. The needle 3828 may be separated from the applicator housing.

The pull tab (not shown in FIG. 212) may remain coupled to the needlehub 3856 and may descend or be otherwise be accessible by a user to pullon the needle hub 3856 with the needle 3828 locked therein.

FIG. 213, for example, illustrates the applicator 3870 having beenwithdrawn from the individual's skin with the pull tab 3858 danglingfrom the receiver of the applicator housing and accessible for a user topull. The pull tab 3858 may unfold into a ring shape and may bepositioned downward of the lower opening of the applicator housing. Therotatable releasable coupler 3892 may be decoupled from the needle hub3856 to allow for a pull force on the pull tab 3858 to release theneedle hub 3856 from the applicator 3870. The needle hub 3856 may rotateout of the applicator 3870, with the coupling member 3814 that wascoupled to the rotatable releasable coupler 3892 releasing prior to thecoupling member 3814 coupled to the opposite static releasable coupler3890 shown in FIG. 203.

FIG. 214, for example, illustrates a user grasping the pull tab 3858 topull the unit of the used needle, covered by the needle cover 3824 ofthe needle hub 3816, out of the applicator 3870.

In embodiments, the applicator system of FIGS. 198-214 may be modifiedto allow for a user to operate the release actuator with a controldevice. The control device may comprise a device such as a button thatmay be pushed by a user to operate the release actuator. In anembodiment as shown in FIGS. 215-223, the control device may beconfigured to be operated in a first operation to activate an insertionactuator configured to insert a needle into the individual's skin, andmay be configured to be operated in a second operation following thefirst operation to activate the release actuator.

FIG. 215, for example, illustrates components of an applicator 4000 thatmay be utilized. The applicator 4000 may be configured similarly as theapplicator 3870 of FIGS. 198-214 unless indicated or stated otherwise.The applicator 4000 may include an applicator housing 4002 that may havean outer housing 4004 with a top cover 4006 and may include an interiorhousing 4008.

The applicator housing 4002 may be configured to be gripped by anindividual to apply the transcutaneous analyte sensor into theindividual's skin. The applicator housing may include a side portion, atop portion and a bottom portion including an opening 4014 (marked inFIG. 216) for the transcutaneous analyte sensor to be deployed from tobe inserted into the individual's skin. The receiver of the applicatorhousing may be configured to receive a cartridge through the opening ofthe bottom portion.

The outer housing 4004 may comprise an outer surface of the applicator4000 and may include an aperture 4009 configured for a control device4010 to pass through.

The interior housing 4008 may be positioned within the outer housing4004 and may include a central cavity 4012 (marked in FIG. 216) forcomponents of the applicator 4000 to be positioned within. The interiorhousing 4008 may be configured to be biased away from the outer housing4004 via the force of biasing members such as leaf springs or coilsprings that may press against the top cover 4006 and bias the interiorhousing 4008 downward.

The interior housing 4008 may include the lower opening 4014 at a bottomsurface of the interior housing 4008 for the transcutaneous analytesensor, and the needle and housing of the on-skin sensor assembly to bedeployed from.

FIG. 215 illustrates a perspective view of a first carriage 4016 thatmay comprise a retraction carriage for retracting the needle from theindividual's skin following insertion of the needle. The first carriage4016 may be configured similarly as the first carriage 3888 shown inFIG. 203, including use of a static or non-rotating releasable coupler4017 and a rotatable releasable coupler 4018. The static releasablecoupler 4017 and the rotatable releasable coupler 4018 may be configuredsimilarly as the respective releasable couplers 3890, 3892 shown in FIG.203.

One or more of the releasable couplers 4017, 4018 may be configured toretain a needle to the applicator housing following insertion of thetranscutaneous analyte sensor into the individual's skin and removal ofthe applicator housing from the transcutaneous analyte sensor, andrelease the needle from within the applicator housing followinginsertion of the transcutaneous analyte sensor into the individual'sskin. The one or more releasable couplers 4017, 4018 may be configuredto couple to the needle hub of the needle.

The first carriage 4016 may include a central channel 4020 that a slidebody 4022 of a release actuator may be positioned within. The centralchannel 4020 may be configured to allow the slide body 4022 to slidetherein to press against the needle hub of a used needle to eject theused needle from the applicator 4000.

The first carriage 4016 may further include coupler releases in the formof deflectors 4024 configured to release a coupler to allow the carriage4016 to move relative to the insertion carriage 4026. The deflectors4024, for example, may be configured to deflect the releasable couplers4028 of the insertion carriage 4026 shown in FIG. 216 to release thecarriages 4016, 4026 from each other. The releasable couplers 4028 mayrelease to allow the driver 4048 to move the carriages 4026, 4032 awayfrom each other. The releasable couplers 4028 may be configured toresist the force of the driver 4048. The releasable couplers 4028 may beconfigured to automatically release upon contact with the couplerrelease.

The first carriage 4016 may further include protrusions 4030 that retainthe first carriage 4016 to the second carriage 4032.

The second carriage 4032 may include support surfaces 4034 for theprotrusions 4030 to contact to keep the carriages 4032, 4016 engagedwith each other. The second carriage 4032 may further include supportsurfaces 4036 for the releasable couplers 4028 shown in FIG. 216 toengage with. The second carriage 4032 may further include a centralchannel 4038 for the first carriage 4016 to be positioned within.

An insertion carriage 4026 may include the releasable couplers 4028(shown in FIG. 216) for engaging with the support surface 4036 of thesecond carriage 4032. The insertion carriage 4026 may comprise acomponent of an actuator or insertion actuator that may be coupled tothe applicator housing and configured to insert a needle and thetranscutaneous analyte sensor into the individual's skin. The insertioncarriage 4026 may be configured to slide relative to the applicatorhousing and configured to be slid by the driver 4046.

The insertion carriage 4026 may further include coupling members 4040for engaging with a releasable coupler 4042 of the interior housing 4008(as marked in FIG. 220). The insertion carriage 4026 may include acentral channel 4044 for the carriages 4016, 4032 to be positionedwithin.

The applicator 4000 may further include a driver 4046 in the form ofsprings configured to drive the entire assembly of carriages, includingthe insertion carriage 4026 downward to drive the needle into theindividual's skin to insert the transcutaneous analyte sensor into theindividual's skin. The applicator 4000 may further include a driver 4048in the form of springs configured to retract the carriages 4016, 4032 toretract the needle from the individual's skin following deployment.

The applicator 4000 may include a control device 4010 that may beactivated to cause the transcutaneous analyte sensor of the on-skinsensor assembly to be inserted into the individual's skin. The controldevice 4010 may be operated by an individual. For example, the controldevice 4010 may comprise a button that is pressed to activate aninsertion actuator of the applicator 4000. Referring to FIG. 219, thecontrol device 4010 may include a pressing surface 4049 that may beconfigured to press against the coupling member 4040 of the insertioncarriage 4026 to release the insertion carriage 4026 from the applicatorhousing 4002 and allow the insertion carriage 4026 to descend and insertthe transcutaneous analyte sensor into the individual's skin. Thecontrol device 4010 may further include locking surfaces 4050 configuredto engage locks 4052 of the insertion carriage 4026. Referring to FIG.216, the control device 4010 may further include a locking surface 4054configured to engage a lock 4056 of a slide lock 4058 or slide shuttle.

Referring to FIG. 215, the control device 4010 in embodiments mayinclude a sub-control device 4060 that may be configured to extend fromthe control device 4010 to provide a different operation of the controldevice 4010. The sub-control device 4060 may comprise a protrusion thatmay be configured to extend from the control device 4010 inward withrespect to the applicator 4000. Thus, the overall length of the controldevice 4010 may be increased upon deployment of the sub-control device4060. The sub-control device 4060 may include a pressing surface 4061(marked in FIG. 216) that may be configured to press against the slidebody 4022. Referring to FIG. 217, the sub-control device 4060 may bepositioned within a channel of the control device 4010 prior toextension of the sub-control device 4060. Upon extension of thesub-control device 4060, a lock 4062 may be released outward from thechannel and may be configured to lock the extension of the sub-controldevice 4060 relative to the control device 4010 (as shown in FIG. 222for example).

Referring to FIG. 215, the applicator 4000 may include a slide lock 4058or slide shuttle that may be configured to slide to lock the controldevice 4010 in position. The slide lock 4058 may include one or morebiasing members 4064 that may bias the slide lock 4058 downward to alocked position, which may be overcome with an upward movement of theinsertion carriage 4026. The slide lock 4058 may include the lock 4056for locking to the locking surface 4054 of the control device 4010. Theslide lock 4058 may include a stop 4059 for impeding inward movement ofthe control device 4010.

The applicator 4000 may include the slide body 4022, which may have anangled contact surface 4066. The slide body 4022 may include a pressingsurface 4068 (marked in FIG. 216) for pressing against a needle hub ofthe needle to release from the applicator 4000.

A cartridge that may be utilized with the applicator 4000 may be similarto the cartridge as discussed in regard to FIGS. 198-202 or may haveanother form.

In assembly, similar to the embodiment of FIGS. 198-214, the firstcarriage 4016 may be positioned within the channel 4038 of the secondcarriage 4032, and the carriages 4016, 4032 may be positioned within thecentral channel 4044 of the insertion carriage 4026. The assembly may bepositioned within the interior housing 4008 shown in FIG. 215.

FIG. 216 illustrates a cross sectional view of the applicator 4000 withthe carriages 4016, 4026, 4032 assembled and positioned within theinterior housing 4008. The interior housing 4008 may be positionedwithin the outer housing 4004 and may be configured to slide within theouter housing 4004. A force applied upwards against the interior housing4008, by the skin of an individual, for example, may move the interiorhousing 4008 upwards within the outer housing 4004.

FIGS. 216-223 illustrate steps of a method that may utilize theapplicator 4000. Referring to FIG. 216, in the initial configuration,the control device 4010 may be locked in a retracted position by theslide lock 4058. The slide lock 4058 may be held in a lowered position.The lock 4056 of the slide lock 4058, for example, may engage thelocking surface 4054 of the control device 4010 to hold the controldevice 4010 in the retracted position. The stop 4059 may impede inwardpressing movement of the control device 4010.

The control device 4010 may be held flush with the outer surface of theapplicator housing 4002. As such, the position of the control device4010 may serve as a tactile and visual indicator that the applicator4000 is not in a configuration to deploy a transcutaneous analyte sensorto the individual's skin. The position of the control device 4010 mayindicate that the control device 4010 should not be pressed by the userat this point to perform an operation.

FIG. 217 illustrates an upper cross sectional view of the applicator4000 in the configuration shown in FIG. 216. The control device 4010 isshown flush with the outer surface of the applicator housing 4002 andthe sub-control device 4060 is shown in a retracted configurationpositioned within the control device 4010.

A cartridge, such as cartridge 3800 shown in FIGS. 198-202, may beinserted into the receiver of the applicator 4000. Upon initialinsertion, the first carriage 4016 may couple to the needle hub 3856 ina similar manner as the first carriage 3888 discussed in regard to theembodiments of FIGS. 198-214.

The cartridge 3800 may be inserted into the applicator housing toprovide energy to the insertion actuator and the retraction actuator.The force applied by the cartridge 3800 to the insertion and retractionactuators may provide energy to the insertion and retraction actuators.The insertion of the cartridge 3800 may provide energy to the drivers4046, 4048. In an embodiment in which the drivers 4046, 4048 comprisesprings, the insertion of the cartridge into the receiver may compressthe springs. The cartridge 3800 may include a pressing surface forpressing against the insertion and retraction actuators for providingenergy to the actuators.

An upward movement of the insertion carriage 4026 may raise the positionof the slide lock 4058. FIG. 218, for example, illustrates the cartridge3800 after it has been withdrawn from the receiver of the applicatorhousing 4002, with the needle hub 3856 remaining coupled to thereleasable couplers 4018, 4017. The insertion carriage 4026 has beenraised by the insertion of the cartridge 3800. The insertion carriage4026 has pressed against the slide lock 4058 to raise the slide lock4058 and release the lock 4056 from the locking surface 4054 of thecontrol device 4010. As such, the control device 4010 may protrude fromthe outer surface of the applicator housing 4002 to a distance.

FIG. 219 illustrates an upper cross sectional view of the applicator4000 in the configuration shown in FIG. 218. The protrusion of thecontrol device 4010 may be limited by the locking surfaces 4050contacting the locks 4052 of the insertion carriage 4026. Further, thesub-control device 4060 may not yet be fully extended from the controldevice 4010 and the lock 4062 may not yet be deployed.

FIG. 220 illustrates a cross sectional view of the configuration shownin FIG. 219, with the pressing surface 4049 of the control device 4010shown to be in position to decouple the coupling members 4040 of theinsertion carriage 4026 from the releasable coupler 4042 of theapplicator housing 4002.

The cartridge 3800 may be removed from the applicator housing prior tothe needle being inserted into the individual's skin to insert thetranscutaneous analyte sensor into the individual's skin.

The control device 4010 may be pressed to release the coupling members4040 of the insertion carriage 4026 from the releasable coupler 4042 ofthe applicator housing 4002 to allow the needle and transcutaneousanalyte sensor to be deployed in a similar manner as discussed in regardto the embodiments of FIGS. 198-214.

FIG. 221 illustrates the configuration of the carriages 4016, 4026, 4032after insertion of the transcutaneous analyte sensor and retraction ofthe needle. The needle is not shown in FIG. 221 for clarity, yet wouldbe rotated into the needle cover via a deflection surface of theinsertion carriage 4026, in a similar manner as discussed in regard tothe embodiments of FIGS. 198-214. The needle cover may contact thedeflection surface, such that the retraction actuator comprising thecarriages 4032, 4016 and the driver 4048 rotates the needle into theneedle cover. The driver 4048 may drive the needle out of theindividual's skin. The driver 4048 may slide the carriage 4032, 4016relative to the applicator housing. The retraction actuator may retractthe needle from the individual's skin following insertion of thetranscutaneous analyte sensor into the individual's skin. The retractionactuator may be configured to automatically operate upon the needleinserting the transcutaneous analyte sensor into the individual's skin.The retraction actuator may position the needle into the needle cover,and may rotate the needle into the needle cover.

The retraction actuator of the applicator 4000 may be configured toactivate based on a force of contact with the individual's skin at adeployment site of the transcutaneous analyte sensor. The retractionactuator of the applicator 4000 may activate at the point of contactwith the individual's skin. For example, if the individual's skinprotrudes into the receiver of the applicator housing then theretraction actuator may activate at the position of the individual'sskin rather than at a defined position relative to the applicator. Thisfeature may be beneficial in a case where skin protrudes greatly intothe receiver of the applicator, to allow for the retraction actuator toactivate due to the force of contact with the individual's skin and thusat the position of the individual's skin.

The retraction actuator may operate based on the insertion carriage 4026over traveling with respect to the first carriage 4016. The insertioncarriage 4026 may displace relative to the first carriage 4016 based oncontact with the individual's skin to operate the release actuator. Thedownward movement of the first carriage 4016 may be impeded by contactwith the individual's skin, thus causing the insertion carriage 4026 tomove downward relative to the first carriage 4016 and displacingrelative to the first carriage 4016. Such displacement may cause therelease of the releasable coupler 4028 and the retraction of the needle.

Following deployment of the transcutaneous analyte sensor, the insertioncarriage 4026 may be in a lowered position, which lowers the locks 4052shown in FIG. 219. As such, referring to the upper cross sectional viewof the applicator 4000 shown in FIG. 222, the control device 4010 mayprotrude to a distance that is further than the position shown in FIGS.218 and 219 due to the locks 4052 shown in FIG. 219 being lowered. Thelocking surfaces 4050 may engage the outer housing 4004 to impedefurther outward movement of the control device 4010.

The control device 4010 may protrude to a distance that allows thesub-control device 4060 to extend inward from the control device 4010and have the lock 4062 deploy. The lock 4062 may extend outward from thechannel of the control device 4010 to contact an interior surface of thecontrol device 4010, and lock the position of the sub-control device4060 relative to the control device 4010 upon an inward pressingmovement of the control device 4010.

The pressing surface 4061 of the sub-control device 4060 may further bealigned with the angled contact surface 4066 of the slide body 4022 in aconfiguration as shown in FIG. 222.

Referring to FIG. 223, the release actuator may include componentscomprising the control device 4010 and sub-control device 4060 and theslide body 4022. The release actuator may be configured to release theneedle from the releasable coupler 4018. The control device 4010 andsub-control device 4060 may be operated by an individual to cause theneedle to release from the releasable coupler 4018. The control device4010 may be pressed inward to move the sub-control device 4060 inwardand press against the slide body 4022. The force applied by thesub-control device 4060 inward may be against the angled contact surface4066, thus causing the release actuator in the form of the slide body4022 to move downward.

The pressing surface 4068 of the slide body 4022 may contact the needlehub 3816 to cause the needle hub to release from the applicator 4000.The release actuator may release the needle from the releasable couplerto allow the needle to be passed through the opening. The needle may bereleased while covered with the needle cover. The needle and needlecover may form a unit for ejection from the applicator housing by therelease actuator following insertion of the needle into the individual'sskin. The pressing surface 4068 may apply a force to the needle to ejectthe needle from the needle from the applicator housing 4002. The slidebody 4022 may eject the needle and needle hub 3816 from the applicatorhousing 4002.

The control device 4010 accordingly may be operated in a first operationto activate the insertion actuator, and is configured to be operated ina second operation following the first operation to activate the releaseactuator. The first operation may comprise pressing the control device4010 and the second operation may comprise pressing the control device4010. The control device 4010 may protrude from the applicator housing4002 to a different distance for the first operation than for the secondoperation.

The releasable coupler 4018 may release the needle positioned within theneedle cover from the applicator housing. The needle may be separatedfrom the applicator housing.

The slide lock 4058 may descend and the lock 4056 may lock with thelocking surface 4054 of the control device 4010. The sub-control device4060 may slide back within the channel of the control device 4010 andthe applicator 4000 may return back to a configuration shown in FIG.216.

FIGS. 224-232 illustrate a variation of cartridges as shown in FIGS.146-158, in which the cartridge includes the retraction actuator forretracting the needle from the individual's skin following insertion ofthe transcutaneous analyte sensor into the individual's skin. Theretraction actuator may be configured to automatically operate upon theneedle inserting the transcutaneous analyte sensor into the individual'sskin. In an embodiment of FIGS. 224-232, however, the retractionactuator may be configured to activate based on a force of contact withthe individual's skin at a deployment site of the transcutaneous analytesensor.

FIG. 224, for example, illustrates a construction of a cartridge 4100including a retraction actuator 4102 positioned within the cartridge4100. The cartridge 4100 may have features similar as the cartridge 1500shown in FIG. 146, and may include an upper removable cover 4104, alower removable cover 4106, a body 4108 and may include the wearablehousing 4109, transcutaneous analyte sensor, and the needle. A patch4111 may be coupled to the wearable housing 4109 and positioned withinthe cartridge 4100. A first retraction carriage 4110, a secondretraction carriage 4112 and a driver 4114 may be positioned within thecartridge 4100.

The first retraction carriage 4110 may couple to a needle hub 4116 ofthe needle 4117 (marked in FIG. 226) and may include arms 4118 extendingoutward from the needle hub 4116 and configured to contact interiorportions of the cartridge 4100 to rotationally orient the firstretraction carriage 4110 within the cartridge 4100. The first retractioncarriage 4110 may include coupling members 4120 in the form ofprotrusions for coupling to releasable couplers of the insertioncarriage 4122.

The second retraction carriage 4112 may include a releasable coupler4124 for coupling with a portion of the control device 1523 shown inFIG. 147 for example. Referring to FIG. 225, the second retractioncarriage 4112 may include a channel 4125 for receiving a portion of theinsertion carriage 4122 and for the needle hub 4116 to pass through. Thesecond retraction carriage 4112 may include support surfaces 4132 forabutting releasable couplers 4130 of the insertion carriage 4122 toprevent deflection of the releasable couplers 4130 until a desired time.

Referring to FIG. 224, the second retraction carriage 4112 may includepressing surfaces 4133 for pressing against releasable couplers 4134 ofthe insertion carriage 4122.

The second retraction carriage 4112 may further include one or morelocks 4126 protruding from the second retraction carriage 4112 andconfigured to engage an interior portion of the cartridge 4100 toprevent upward or inward pushing of the second retraction carriage 4112following insertion of the needle 4117. The second retraction carriage4112 may be configured to be pushed by the insertion actuator of theapplicator (for example, an insertion carriage 1536 as shown in FIG.147) to insert the needle 4117 and transcutaneous analyte sensor intothe individual's skin. The second retraction carriage 4112 inembodiments may comprise an over travel carriage that is configured toover travel a position of the insertion carriage 4122 upon insertion ofthe needle 4117 and transcutaneous analyte sensor into the individual'sskin. The over travel may cause the first retraction carriage 4110 torelease and retract from the insertion carriage 4122. The insertioncarriage 4122 may displace relative to the second retraction carriage4112 based on contact with the individual's skin to operate the releaseactuator.

The cartridge 4100 may further include the insertion carriage 4122 forretaining the wearable housing 4109. The insertion carriage 4122 may beconfigured to be moved downward via the motion of the second retractioncarriage 4112 to insert the needle and transcutaneous analyte sensorinto the individual's skin. The insertion carriage 4122 may include aninternal cavity 4128 for receiving the second retraction carriage 4112.

The insertion carriage 4122 may include one or more releasable couplers4130 for coupling to the coupling members 4120 of the first retractioncarriage 4110. The releasable couplers 4130 may be configured as supportarms extending upward for coupling with the coupling members 4120 of thefirst retraction carriage 4110. The support arms may be configured todeflect outward from the coupling members 4120 to release from thecoupling members 4120. The support arms may be biased to deflect outwardwith the support surfaces 4132 (marked in FIG. 225) of the secondretraction carriage 4112 moved out of position relative to the supportarms.

The releasable couplers 4130 that couple the insertion carriage 4122 tothe first retraction carriage 4110 may release the first retractioncarriage 4110 from the insertion carriage 4122 to allow the driver 4114to move the first retraction carriage 4110 in a direction away from theinsertion carriage 4122.

The insertion carriage 4122 may include releasable couplers 4134 thatmay be configured to engage the wearable housing 4109 and retain thewearable housing 4109 to the insertion carriage 4122. The releasablecouplers 4134 may comprise deflectable arms that may be biased to engagethe wearable housing 4109 and may be deflectable outward to disengageand release from the wearable housing 4109.

Referring to FIG. 227, the releasable couplers 4134 may include uppercontact surfaces 4137 that may be configured to contact the pressingsurfaces 4133 of the second retraction carriage 4112. The contactbetween the pressing surfaces 4133 and the upper contact surfaces 4137may press the insertion carriage 4122 away from the second retractioncarriage 4112 during use. The force required to deflect the releasablecouplers 4134 outward may comprise a force that must be overcome fordeployment of the wearable housing and retraction of the needle uponcontact with the individual's skin.

The insertion carriage 4122 may further include stops 4136 forcontacting an interior portion of the cartridge 4100 to impede downwardmovement of the insertion carriage 4122 upon release of the releasablecoupler 4124 from the portion of the control device 1523.

The driver 4114 of the retraction actuator may be configured to drivethe needle out of the individual's skin. The first retraction carriage4110 may be configured to slide relative to the applicator housing andmay be configured to be slid by the driver 4114 of the retractionactuator. The driver 4114 may be configured as a spring configured toapply an upward force from the insertion carriage 4122 towards the firstretraction carriage 4110. The driver 4114 may be configured to becompressed between the insertion carriage 4122 and the coupling members4120 of the first retraction carriage 4110, as shown in FIG. 226 forexample.

FIG. 225 illustrates a perspective view of the second retractioncarriage 4112 positioned within the insertion carriage 4122. The needle4117 and needle hub 4116 may pass through a central channel of theinsertion carriage 4122 in assembly, such that the coupling members 4120may engage with the releasable couplers 4130 of the insertion carriage4122.

FIG. 226, for example, illustrates a cross sectional view of the firstretraction carriage 4110 coupled with the releasable couplers 4130 ofthe insertion carriage 4122. The releasable couplers 4130 may bedeflected inward to engage with the coupling members 4120 of the firstretraction carriage 4110 by way of the support surfaces 4132 backing thereleasable couplers 4130 to prevent their outward deflection. The driver4114 may be compressed between the insertion carriage 4122 and thecoupling members 4120 of the first retraction carriage 4110. Theengagement of the releasable couplers 4130 and the coupling members 4120may prevent the release of the driver 4114 until the desired time.

Referring to FIG. 227, the insertion carriage 4122 may be held withinthe cartridge 4100 such that an interior surface 4135 of the cartridge4100 may press against the releasable couplers 4134 that may beconfigured to engage the wearable housing 4109. Such contact between theinterior surface 4135 and the releasable couplers 4134 may reduce thepossibility of the releasable couplers 4134 releasing prematurely andproducing dislodgement of the wearable housing 4109 during transport orotherwise prior to use.

An applicator that may be utilized with the cartridge 4100 may comprisean applicator 1530 as shown in FIG. 147. The cartridge 4100 may insertinto the receiver of the applicator 1530 in a similar manner as thecartridge 1500 shown in FIG. 147. The applicator operates in a similarmanner as the applicator 1530.

The insertion of the cartridge 4100 and the transcutaneous analytesensor 24 into the receiver of the applicator housing 1528 may compressand thus provide energy to the driver 1538 of the insertion actuator.The driver 1538 may be compressed. In an embodiment in which the driver1538 includes a spring, the spring may be compressed by the insertion ofthe cartridge 4100 and the transcutaneous analyte sensor 24 into thereceiver.

With the cartridge 4100 inserted into the receiver of the applicator1530 shown in FIG. 147, the biasing carriage 1534 shown in FIG. 147 maybe compressed to allow the control device 1523 to move in a similarmanner as described in regard to FIG. 131 for example. Upward pressureagainst the cartridge 4100 by the individual's skin presses the biasingcarriage 1534 shown in FIG. 147 upward, to move the stop 1533 marked inFIG. 148, and allow the control device 1523 to move inward to bepressed.

The insertion carriage 1536 may be in contact with the second retractioncarriage 4112 to drive the assembly of carriages 4110, 4112, 4122downward at the desired time.

The control device 1523 shown in FIG. 147 may contact the releasablecoupler 4124 shown in FIG. 224 to release the releasable coupler 4124 ina similar manner as described in regard to FIG. 131 for example. Thecontrol device 1523 may press against the releasable coupler 4124 todisengage the coupler 4124 from a surface and allow the insertioncarriage 1536 to drive the assembly of carriages 4110, 4112, 4122downward.

FIG. 228 illustrates the carriage 1536 having descended. The insertioncarriage 4122 may move downward to insert the needle 4117 into theindividual's skin to insert the transcutaneous analyte sensor into theindividual's skin. Further, the patch 4111 may be applied to theindividual's skin with an adhesive.

The releasable couplers 4134 that may be configured to engage thewearable housing 4109 may displace relative to the interior surface 4135shown in FIG. 227 and may be able to deflect outward from the wearablehousing 4109 at a desired time.

The cartridge 4100 may remain within the receiver of the applicatorhousing 1528 during insertion of the needle 4117 and insertion of thetranscutaneous analyte sensor into the individual's skin, as well asdeployment of the on-skin sensor assembly to the individual's skin.

The retraction actuator of the cartridge 4100 may be configured toactivate based on a force of contact with the individual's skin at adeployment site of the transcutaneous analyte sensor. Such a feature maydiffer from a cartridge 1500 as shown in FIG. 147, for example, whichmay have a retraction actuator that retracts based on a position ordisplacement of the actuator relative to the cartridge 1500 (e.g.,contact between the arms 1520 and the stops 1544). The retractionactuator of the cartridge 4100 may activate at the point of contact withthe individual's skin. For example, as shown in FIG. 228, if theindividual's skin 4138 protrudes into the receiver of the cartridge 4100then the retraction actuator may activate at the position of theindividual's skin 4138 rather than at a defined position relative to thecartridge (as shown in FIG. 151 for example). This feature may bebeneficial in a case where skin protrudes greatly into the receiver ofthe cartridge 4100, to allow for the retraction actuator to activate dueto the force of contact with the individual's skin and thus at theposition of the individual's skin.

The retraction actuator may operate utilizing a carriage that overtravels with respect to another carriage based on contact with theindividual's skin at a deployment site of the transcutaneous analytesensor. For example, the second retraction carriage 4112 may beconfigured to over travel with respect to the insertion carriage 4122upon deployment. Upon deployment, the downward motion of the insertioncarriage 4122 may be impeded based on contact with the individual'sskin. The insertion carriage 4122 may thus cease downward movement alongwith the wearable housing 4109 upon the individual's skin applying aresistive force to the insertion carriage 4122 upon deployment. Thesecond retraction carriage 4112, however, may continue to be pressed bythe insertion carriage 1536 and may continue to travel, or over travel,with respect to the insertion carriage 4122. The insertion carriage 4122may displace relative to the second retraction carriage 4112 based oncontact with the individual's skin to operate the release actuator. Theover travel may cause a displacement of the second retraction carriage4112 downward with respect to the insertion carriage 4122 andaccordingly a displacement of the support surfaces 4132 of the secondretraction carriage 4112 relative to the releasable couplers 4130 of theinsertion carriage 4122. FIG. 228, for example, illustrates the relativedisplacement of the support surfaces 4132 relative to the releasablecouplers 4130.

With the support surfaces 4132 of the second retraction carriage 4112released from the releasable couplers 4130 of the insertion carriage4122, the releasable couplers 4130 may be able to decouple from thecoupling members 4120 of the first retraction carriage 4110. Referringto FIG. 229, the releasable couplers 4130 may deflect outward from thecoupling members 4120 to allow the driver 4114 to expand and retract theneedle 4117 from the individual's skin.

FIG. 230 illustrates that upon the over travel of the second retractioncarriage 4112 with respect to the insertion carriage 4122, the pressingsurfaces 4133 of the second retraction carriage 4112 may press againstthe releasable couplers 4134. The pressing surfaces 4133 may deflect thereleasable couplers 4134 away from the wearable housing 4109 and maydisengage the releasable couplers 4134 from the wearable housing 4109 toallow the wearable housing 4109 to remain on the individual's skin upondeployment.

The cartridge 4100 may be configured to retain the needle 4117 after thecartridge 4100 has been separated from the receiver and the needle 4117has been inserted into the individual's skin.

FIG. 231 illustrates that the locks 4126 of the second retractioncarriage 4112 may engage an interior portion of the cartridge 4100 toprevent upward or inward pushing of the second retraction carriage 4112following insertion of the needle 4117. Such a feature may reduce thepossibility of access by a user of the used needle within the cartridge4100.

In the event that no skin is contacted by the assembly of carriages4110, 4112, 4122, the retraction actuator may yet activate. Referring toFIG. 232, the stops 4136 of the insertion carriage 4122 may contact aninterior portion of the cartridge 4100 to impede downward movement ofthe insertion carriage 4122. Thus, a position or displacement basedactivation may occur if no skin is contacted. The second retractioncarriage 4112 may continue to over travel or displace with respect tothe insertion carriage 4122 and cause the needle 4117 to be retractedfrom the individual's skin. Such a feature may reduce the possibility ofthe needle 4117 remaining extended from the cartridge 4100 if no skin iscontacted upon activation of the insertion actuator.

With the needle 4117 retracted, the cartridge 4100 may then be withdrawnand discarded, to discard the used needle 4117. The applicator mayreturn to the state shown in FIG. 147, for example, for insertion ofanother cartridge.

Variations in the configuration of the cartridge may be provided. FIGS.233-237 illustrate a variation of the cartridge as shown in FIGS.224-232. The cartridge 4200 may include a retraction actuator forretracting the needle from the individual's skin following insertion ofthe transcutaneous analyte sensor into the individual's skin. Theretraction actuator may be configured to automatically operate upon theneedle inserting the transcutaneous analyte sensor into the individual'sskin. The retraction actuator may be configured to activate based on aforce of contact with the individual's skin at a deployment site of thetranscutaneous analyte sensor. The retraction actuator may include adriver 4202 such as a spring that biases carriages 4204, 4206 away fromeach other.

FIG. 233 illustrates a construction of the cartridge 4200 including aretraction actuator 4208 positioned within the cartridge 4200. Thecartridge 4200 may have features similar as the cartridge 4100 shown inFIG. 224, and may include an upper removable cover 4210, a lowerremovable cover 4212, a body 4214 and may include the wearable housing4216, transcutaneous analyte sensor, and the needle. A patch 4218 may becoupled to the wearable housing 4216 and positioned within the cartridge4200. A first retraction carriage 4220, a second retraction carriage4204 and a driver 4202 may be positioned within the cartridge 4200.

The first retraction carriage 4220 may couple to a needle hub 4222 ofthe needle 4224 (marked in FIG. 235) and may include arms 4226 extendingoutward from the needle hub 4222 and configured to contact interiorportions of the cartridge 4200 to rotationally orient the firstretraction carriage 4220 within the cartridge 4200.

The first retraction carriage 4220 may include coupling members 4228 inthe form of support arms having protrusions for coupling to releasablecouplers 4229 of the insertion carriage 4206 (marked in FIG. 235). Thecoupling members 4228 in the form of support arms may be biased todeflect outward.

The first retraction carriage 4220 may include apertures 4230 forreceiving releasable couplers 4231 of the second retraction carriage4204. Support surfaces 4235 (marked in FIG. 234) may form sides of theapertures 4230 for contacting the releasable couplers 4231 of the secondretraction carriage 4204.

The second retraction carriage 4204 may include a releasable coupler4233 for coupling with a portion of the control device 1523 shown inFIG. 147 for example. Referring to FIG. 234, the second retractioncarriage 4204 may include a channel 4234 for receiving a portion of theinsertion carriage 4206 and for the needle hub 4222 to pass through.

Referring to FIG. 235, the second retraction carriage 4204 may includesupport surfaces 4236 for abutting the coupling members 4228 of thefirst retraction carriage 4220. The releasable couplers 4231 of thesecond retraction carriage 4204 may couple to the driver 4202 to retainthe driver 4202 in a compressed state. The releasable couplers 4231 maybe in the form of support arms biased to deflect outward upon releasefrom the apertures 4230 of the first retraction carriage 4220.

Referring to FIG. 234, the second retraction carriage 4204 may furtherinclude one or more locks 4238 protruding from the second retractioncarriage 4204 and configured to engage an interior portion of thecartridge 4200 to prevent upward or inward pushing of the secondretraction carriage 4204 following insertion of the needle 4224.

The second retraction carriage 4204 may be configured to be pushed bythe insertion actuator of the applicator (for example, an insertioncarriage 1536 as shown in FIG. 147) to insert the needle 4224 andtranscutaneous analyte sensor into the individual's skin. The secondretraction carriage 4204 in embodiments may comprise an over travelcarriage that is configured to over travel a position of the insertioncarriage 4206 upon insertion of the needle 4224 and transcutaneousanalyte sensor into the individual's skin. The second retractioncarriage 4204 may displace relative to the insertion carriage 4206 basedon contact with the individual's skin to operate the release actuator.The over travel may cause the first retraction carriage 4220 to releaseand retract from the insertion carriage 4206.

The cartridge 4200 may further include an insertion carriage 4206 forretaining the wearable housing 4216. The insertion carriage 4206 may beconfigured to be moved downward via the motion of the second retractioncarriage 4204 to insert the needle and transcutaneous analyte sensorinto the individual's skin. The insertion carriage 4206 may include aninternal cavity 4243 for receiving the second retraction carriage 4204.

Referring to FIG. 235, the insertion carriage 4206 may include one ormore releasable couplers 4229 for coupling to the coupling members 4228of the first retraction carriage 4220. The releasable couplers 4229 maybe configured to be static and support the coupling members 4228 of thefirst retraction carriage 4220 against the support surfaces 4236.

The releasable couplers 4229 that couple the insertion carriage 4206 tothe first retraction carriage 4220 may release the first retractioncarriage 4220 from the insertion carriage 4206 to allow the driver 4202to move the first retraction carriage 4220 in a direction away from theinsertion carriage 4206.

Referring to FIG. 234, the insertion carriage 4206 may includereleasable couplers 4240 that may be configured to engage the wearablehousing 4216 and retain the wearable housing 4216 to the insertioncarriage 4206. The releasable couplers 4240 may comprise deflectablearms that may be biased to deflect outward from the wearable housing4216 and may be deflectable inward to engage the wearable housing 4216.

The insertion carriage 4206 may further include stops 4242 forcontacting an interior portion of the cartridge 4200 to impede downwardmovement of the insertion carriage 4206 upon release of the releasablecoupler 4233 from the portion of the control device 1523.

The driver 4202 of the retraction actuator may be configured to drivethe needle out of the individual's skin. The first retraction carriage4220 may be configured to slide relative to the applicator housing andmay be configured to be slid by the driver 4202 of the retractionactuator.

The driver 4202 may be configured as a spring configured to apply anupward force from the insertion carriage 4206 towards the secondretraction carriage 4204 and the first retraction carriage 4220. Thespring may be configured to be compressed between the insertion carriage4206 and the releasable couplers 4231 of the second retraction carriage4204, as shown in FIG. 235 for example. The spring may bias theinsertion carriage 4206 away from the second retraction carriage 4204.The spring force may define a force that must be overcome by the contactwith the individual's skin to activate the retraction actuator. Thespring force may be set based on a desired level of the force of contactwith the individual's skin. As such, a greater spring force may resultin a greater force of contact being required to activate the retractionactuator. A lesser spring force may result in a lesser force of contactbeing required to activate the retraction actuator. The spring constantof the spring, or other configuration of the spring, may be set asdesired to define the force that must be overcome by the contact withthe individual's skin.

FIG. 234 illustrates a perspective view of second retraction carriage4204 positioned within the insertion carriage 4206. In assembly, theneedle 4224 and needle hub 4222 may pass through a central channel ofthe insertion carriage 4206. FIG. 235 illustrates a cross sectional viewof the assembled cartridge 4200 with the releasable couplers 4229 of theinsertion carriage 4206 coupled to the coupling members 4228 of thefirst retraction carriage 4220. The releasable couplers 4231 of thesecond retraction carriage 4204 may be coupled to the driver 4202, andmay be supported by the support surfaces 4235 of the first retractioncarriage 4220. The support surfaces 4236 of the second retractioncarriage 4204 may support the coupling members 4228 against thereleasable couplers 4229 of the insertion carriage 4206. As such, thesupport surfaces 4236 may prevent the releasable couplers 4231 fromdeflecting away from the driver 4202 until a desired time, and thesupport surfaces 4236 may prevent the coupling members 4228 fromdeflecting away from the releasable couplers 4229 until a desired time.

The insertion carriage 4206 may be held within the cartridge 4200 suchthat an interior surface of the cartridge 4200 may press against thereleasable couplers 4240 that may be configured to engage the wearablehousing 4216. Such contact between the interior surface and thereleasable couplers 4240 may reduce the possibility of the releasablecouplers 4240 releasing prematurely and producing dislodgement of thewearable housing 4216 during transport or otherwise prior to use.

An applicator that may be utilized with the cartridge 4200 may comprisean applicator 1530 as shown in FIG. 147. The cartridge 4200 may insertinto the receiver of the applicator 1530 in a similar manner as thecartridge 1500 shown in FIG. 147. The applicator operates in a similarmanner as the applicator 1530.

The insertion of the cartridge 4200 and the transcutaneous analytesensor 24 into the receiver of the applicator housing 1528 may compressand thus provide energy to the driver 1538 of the insertion actuator.The driver 1538 may be compressed. In an embodiment in which the driver1538 includes a spring, the spring may be compressed by the insertion ofthe cartridge 4200 and the transcutaneous analyte sensor 24 into thereceiver.

With the cartridge 4200 inserted into the receiver of the applicator1530 shown in FIG. 147, the biasing carriage 1534 shown in FIG. 147 maybe compressed to allow the control device 1523 to move in a similarmanner as described in regard to FIG. 131 for example. Upward pressureagainst the cartridge 4200 by the individual's skin presses the biasingcarriage 1534 shown in FIG. 147 upward, to move the stop 1533 marked inFIG. 148, and allow the control device 1523 to move inward to bepressed.

The insertion carriage 1536 may be in contact with the second retractioncarriage 4204 to drive the assembly of carriages 4206, 4204, 4220downward.

The control device 1523 shown in FIG. 147 may contact the releasablecoupler 4233 shown in FIG. 233 to release the releasable coupler 4233 ina similar manner as described in regard to FIG. 131 for example. Thecontrol device 1523 may press against the releasable coupler 4233 todisengage the coupler 4233 from a surface and allow the insertioncarriage 1536 to drive the assembly of carriages 4206, 4204, 4220downward.

FIG. 236 illustrates the carriage 1536 having descended. The insertioncarriage 4206 may move downward to insert the needle 4224 into theindividual's skin to insert the transcutaneous analyte sensor into theindividual's skin. Further, the patch 4218 may be applied to theindividual's skin with an adhesive.

The cartridge 4200 may remain within the receiver of the applicatorhousing 1528 during insertion of the needle 4117 and insertion of thetranscutaneous analyte sensor 24 into the individual's skin, as well asdeployment of the on-skin sensor assembly 12 to the individual's skin.

The retraction actuator of the cartridge 4200 may be configured toactivate based on a force of contact with the individual's skin at adeployment site of the transcutaneous analyte sensor. The retractionactuator of the cartridge 4200 may activate at the point of contact withthe individual's skin, in a similar manner as the cartridge 4100 shownin FIG. 224.

The retraction actuator may operate utilizing a carriage that overtravels with respect to another carriage based on contact with theindividual's skin at a deployment site of the transcutaneous analytesensor. For example, the second retraction carriage 4204 may beconfigured to over travel with respect to the insertion carriage 4206upon deployment. Upon deployment, the downward motion of the insertioncarriage 4206 may be impeded based on contact with the individual'sskin. The insertion carriage 4206 may thus cease downward movement alongwith the wearable housing 4216 upon the individual's skin applying aresistive force to the insertion carriage 4206 upon deployment. Thesecond retraction carriage 4204, however, may continue to be pressed bythe insertion carriage 1536 and may continue to travel, or over travel,with respect to the insertion carriage 4206. The over travel may cause adisplacement of the second retraction carriage 4204 downward withrespect to the insertion carriage 4206. The force to be overcome by theforce of contact with the individual's skin may be the spring force ofthe driver 4202.

With the spring force of the driver 4202 overcome, the support surfaces4236 may displace downward relative to the coupling members 4228 of thefirst retraction carriage 4220 and may allow the coupling members 4228to deflect inward to decouple from the releasable couplers 4229 of theinsertion carriage 4206. The support surfaces 4235 of the firstretraction carriage 4220 may displace upward relative to the releasablecouplers 4231 of the second retraction carriage 4204 to allow thereleasable couplers 4231 to deflect outward. The outward deflection ofthe releasable couplers 4231 of the second retraction carriage 4204 mayallow the driver 4202 to be released and expand to apply an upward forceto the first retraction carriage 4220. The upward force of the driver4202 upon the first retraction carriage 4220 may retract the needle 4224from the individual's skin.

The cartridge 4200 may be configured to retain the needle 4224 after thecartridge 4200 has been separated from the receiver and the needle 4224has been inserted into the individual's skin.

Referring to FIG. 237, the releasable couplers 4240 that may beconfigured to engage the wearable housing 4216 may displace relative tothe interior surface of the cartridge 4200 and may deflect outward fromthe wearable housing 4216 to release from the wearable housing 4216.

The locks 4238 of the second retraction carriage 4204 may operate in asimilar manner as the locks 4126 shown in FIG. 231. The stops 4242 ofthe carriage 4204 may operate in a similar manner as the stops 4136shown in FIG. 232.

With the needle 4224 retracted, the cartridge 4200 may then be withdrawnand discarded, to discard the used needle 4224. The applicator mayreturn to the state shown in FIG. 147, for example, for insertion ofanother cartridge.

Variations in the configuration of the cartridge may be provided.

FIG. 238-240 illustrate an embodiment in which a needle hub 4301 may beintegrated with a retraction carriage 4302. The retraction carriage 4302may be configured as a ring that extends circumferentially about aninsertion carriage 4304. A driver 4305 may be configured as a springthat extends in a ring circumferentially about the outer periphery ofthe insertion carriage 4304. The driver 4305 may be configured to applyan upward force against the retraction carriage 4302 to retract theneedle hub 4301 and needle coupled thereto.

FIG. 239 illustrates the retraction carriage 4302 separate from theinsertion carriage 4304. The retraction carriage 4302 may include firstreleasable couplers 4306 that may be configured to engage a wearablehousing 4307. The retraction carriage 4302 may further include secondreleasable couplers 4308 that may be configured to couple to theinsertion carriage 4304. For example, the second releasable couplers4308 may be in the form of deflectable support arms that may passthrough openings 4310 in the insertion carriage 4304 shown in FIG. 240.The retraction carriage 4302 may include support surfaces 4312 forsupporting releasable couplers 4314 of the insertion carriage 4304 shownin FIG. 240.

FIG. 240 illustrates the insertion carriage 4304 with the retractioncarriage 4302 shown removed from the upper surface of the insertioncarriage 4304. The insertion carriage 4304 may include the releasablecouplers 4314 configured to retain the driver 4305 in a compressedconfiguration and configured to deflect inward from the driver 4305 torelease the driver 4305.

In operation, the retraction carriage 4302 may be configured to activatebased on a force of contact with the individual's skin at a deploymentsite of the transcutaneous analyte sensor, similar to the operation ofthe cartridges 4200, 4100. The insertion carriage 4304 may over travelwith respect to the retraction carriage 4302 based on contact with theindividual's skin at a deployment site of the transcutaneous analytesensor. The insertion carriage 4304 may displace relative to theretraction carriage 4302 based on contact with the individual's skin tooperate the release actuator. For example, the carriages 4304, 4302 maybe advanced downward until the wearable housing 4307 contacts theindividual's skin. The upward force applied to the first releasablecouplers 4306 of the retraction carriage 4302 may cause the secondreleasable couplers 4308 of the retraction carriage 4302 to release fromthe openings 4310 shown in FIG. 240.

The relative displacement of the retraction carriage 4302 from theinsertion carriage 4304 may cause the support surfaces 4312 to displacefrom the releasable couplers 4314 of the insertion carriage 4304. Thereleasable couplers 4314 of the insertion carriage 4304 accordingly maymove inward to release the driver 4305, which may press upward againstthe retraction carriage 4302 to retract the needle hub 4301 and theneedle.

Variations in the configuration of the cartridge may be provided.

In embodiments, the applicators and cartridges utilized herein mayutilize a releasable coupler 4400 as shown in FIGS. 241-244. Thereleasable coupler 4400 may be utilized to couple to a cartridge 4402that may be configured similarly as any cartridge disclosed herein,including the cartridges disclosed in regard to FIGS. 146-158 and198-240. The cartridge, for example, may be a cartridge that retains aused needle following insertion of the needle, and may be a cartridgeincluding a retraction actuator. Other cartridges may be utilized withthe releasable coupler 4400. An applicator that may utilize thereleasable coupler 4400 may include an applicator 1530 as described inregard to FIG. 147, or another form of applicator as desired.

The releasable coupler 4400 that may be utilized with embodiment herein,including the cartridges disclosed in regard to FIGS. 146-158 and198-240, may be configured to retain the needle at least partiallywithin the applicator housing following insertion of a transcutaneousanalyte sensor into the individual's skin and removal of the applicatorhousing from the transcutaneous analyte sensor, and configured torelease the needle from within the applicator housing followinginsertion of the transcutaneous analyte sensor into the individual'sskin. The releasable coupler 4400 may comprise a cartridge catch thatretains the cartridge to the applicator housing. The releasable coupler4400 may be configured to release the cartridge from the applicatorhousing.

The releasable coupler 4400 may be released via operation of a releaseactuator, which may include a lever arm 4404 coupled to the releasablecoupler 4400. The lever arm 4404 may further include a detent 4406. Thelever arm 4404 may further include a contact surface 4408 that may beangled for contact with an angled pressing surface 4409 of an insertioncarriage 4410, which may be configured similarly as the insertioncarriage 1536 discussed in regard to FIG. 147.

A biasing spring 4412, such as a leaf spring, may be configured to biasthe lever arm 4404 inward towards the insertion carriage 4410 and thecartridge 4402.

The lever arm 4404 may have a lower portion 4414 and an upper portion4416, with the lower portion 4414 configured to couple to the applicatorhousing 4413 with a pivot to cause the upper portion 4416 to rotateabout the pivot within the applicator housing 4413. The rotation of thelever arm 4404 may cause the releasable coupler 4400 and the detent 4406to rotate towards the cartridge 4402 and away from the cartridge 4402 asdesired.

The cartridge 4402 may include an outer surface with features forengaging with the releasable coupler 4400 and the detent 4406. Thecartridge 4402, for example, may include a coupling member in the formof a ledge surface 4418 for the releasable coupler 4400 to insert intoand lock to. The ledge surface 4418, for example, may comprise aflattened surface that a corresponding flattened surface 4420 of thereleasable coupler 4400 may contact to maintain a lock between thereleasable coupler 4400 and the ledge surface 4418.

Referring to FIG. 243, the cartridge 4402 may include a receiving recess4423 for receiving the detent 4406 of the lever arm 4404.

Referring to FIG. 241, prior to insertion of the cartridge 4402 into thereceiver of the applicator housing 4413, the insertion carriage 4410 maybe in a lowered position. The pressing surface 4409 of the insertioncarriage 4410 may press against the contact surface 4408 to push thelever arm 4404 outward. The lever arm 4404 pressed outward may clear apath for the cartridge 4402 to be inserted into the receiver of theapplicator housing 4413.

The cartridge 4402 may be inserted into the receiver, as shown in FIG.241, for example. The upward movement of the cartridge 4402 may pressthe insertion carriage 4410 upward, which may cause the pressing surface4409 of the insertion carriage 4410 to move upward. The detent 4406 maybe configured to slide along the outer surface of the cartridge 4402 toallow for insertion of the cartridge 4402 into the receiver.

FIG. 242, for example, illustrates further insertion of the cartridge4402 into the receiver of the applicator housing 4413. The pressingsurface 4409 of the insertion carriage 4410 may separate from thecontact surface 4408 of the lever arm 4404. The detent 4406, however,may press against the outer surface of the cartridge 4402 to retain theoutward position of the lever arm 4404.

FIG. 243 illustrates the cartridge fully inserted into the receiver ofthe applicator housing 4413. The detent 4406 may slide into thereceiving recess 4423 and may move inward towards the cartridge 4402.The biasing spring 4412, for example, may press the detent 4406 into thereceiving recess 4423. The releasable coupler 4400 may insert into thecoupling member of the cartridge 4402 and may rest upon the ledgesurface 4418 of the cartridge 4402. The releasable coupler 4400 mayprevent the cartridge 4402 from being released from the applicator untila desired time.

The applicator may be operated to insert the needle and transcutaneousanalyte sensor into the individual's skin. The insertion carriage 4410may be released and may move downward. The downward motion of theinsertion carriage 4410 may cause the pressing surface 4409 to contactthe angled contact surface 4408 and deflect the lever arm 4404 outward.The releasable coupler 4400 may decouple from the ledge surface 4418 tounlock the cartridge 4402 from the applicator.

Referring to FIG. 244, the detent 4406 may be positioned to slide alongthe outer surface of the cartridge 4402 to provide frictional engagementwith the cartridge 4402. Such frictional engagement may reduce thepossibility of the cartridge 4402 dropping from the receiver of theapplicator housing 4413, yet able to be pulled from the receiver at adesired time by the user. The pressing surface 4409 of the insertioncarriage 4410 may press against the contact surface 4408 to keep thedetent 4406 and the releasable coupler 4400 disengaged from the ledgesurface 4418 and the receiving recess 4423 of the cartridge 4402.

With the cartridge 4402 removed, the applicator may be in aconfiguration to receive another cartridge for deployment of anotherneedle and transcutaneous analyte sensor to the individual's skin.

Variations in the configuration of the cartridge may be provided.

FIG. 245 illustrates an embodiment of a cartridge 4500 in which thecartridge body 4501 may include a removable body 4502 configured toretain a used needle and to be removable from the cartridge body 4501 toseparate the used needle from the cartridge body 4501.

The cartridge 4500 may be configured to retain components that othercartridges disclosed herein may retain, including a needle or unusedneedle, a transcutaneous analyte sensor, and/or a wearable housing forthe transcutaneous analyte sensor.

The cartridge 4500 may be configured as a cartridge that may retain theused needle following insertion, or may be configured as another form ofcartridge. The cartridge 4500 may include a retraction actuator or maybe configured as another form of cartridge as desired.

The removable body 4502 may be removed by a user following insertion ofthe used needle. The removable body 4502, for example, may comprise aninsert positioned within the cartridge body 4501. A pull body 4506 suchas a ring may be coupled to the removable body 4502. The pull body 4506may be configured to be gripped by a user and pulled to remove theremovable body 4502 from the portion of the cartridge body 4504remaining after the removable body 4502 is removed from the cartridgebody 4504. The removable body 4502 may comprise a needle cover forcovering the used needle.

In embodiments, the removable body 4502 may have a smaller volume thanthe portion of the cartridge body 4504 remaining after the removablebody 4502 is removed from the cartridge body 4504. The removable body4502 may thus comprise less material to be disposed of in a biologicalwaste container than the entire cartridge 4500. As such, reducedmaterial may be provided in a biological waste container, with theremaining cartridge body 4504 comprising a larger volume to be placed ina standard waste or recyclable material container. Further, a user maydesirably be able to separate biological waste from materials that maybe recycled by a recycling facility, such as the remaining cartridgebody 4504.

Variations in the cartridge may be provided. FIGS. 246A-B for example,illustrate a removable body 4602 comprising an insert configured to besurrounded by the remaining cartridge body 4604 in the form of a shellabout the removable body 4602. The removable body 4602 may be pulledfrom the remaining cartridge body 4604 and disposed in a biologicalwaste container, separate from the remaining cartridge body 4604.

FIGS. 247A-B illustrate a removable body 4702 forming an outer surfaceof the cartridge 4700. The removable body 4702 may comprise an upperportion of the cartridge 4700, with an outer surface that is gripped toseparate from the remaining cartridge body 4704.

FIGS. 248A-B illustrate a removable body 4802 forming an outer surfaceof the cartridge 4800. The removable body 4802 may configured to besurrounded by the remaining cartridge body 4804 in the form of a shellabout the removable body 4802. The remaining cartridge body 4804 may besplit apart to release the removable body 4802 from the cartridge body4804, as represented by the arrows in FIG. 248B.

The embodiments disclosed herein may each be configured to performmethods disclosed herein. Such methods may include utilizing an actuatorcoupled to an applicator housing to insert a needle into theindividual's skin to insert the transcutaneous analyte sensor into theindividual's skin, the needle being coupled to the applicator housing.Such methods may include withdrawing the applicator housing from theindividual's skin with the needle coupled to the applicator housingafter the needle has inserted the transcutaneous analyte sensor into theindividual's skin. Such methods may include separating the needle fromthe applicator housing. The actuators disclosed herein may be reloadableactuators configured to insert multiple different needles into theindividual's skin. The actuator may comprise a reusable actuator.

The various components disclosed herein may be varied as desired. Forexample, the actuators, couplers, coupler releases, control devices,drivers, housings, and other components may be provided in a variety offorms as desired. In a non-limiting manner, the actuators may compriseassemblies or mechanisms for performing the defined operations. Theactuators may be electrically actuated in certain embodiments. Thecouplers, releasable couplers, and coupler releases may include avariety of forms of bodies and openings, including protrusions, latches,ledges, locks, clips, snaps, pressing surfaces or other forms. Thecouplers, releasable couplers, and coupler releases may be magnetic asdesired and may be electrically controlled (electromagnetic control).The control devices may be manually operated, or may be remotelyoperated via electrical control which may include transmission ofwireless control signals. Other forms of electrical control devices(switches, motion sensors, or other electrical control devices) may beutilized. The drivers may comprise springs as disclosed herein, or maycomprise other forms of drivers including solenoids, magnetic railactuation, gas springs, compressed gas (for expansion to provide drivingmovement), among other forms of drivers. The housings may have a varietyof forms as desired. Each component disclosed herein may comprise anassembly or mechanism for performing the defined operation of thatcomponent. Components across embodiments may be substituted, varied,modified, or added to as desired across embodiments.

The above description presents the best mode contemplated for carryingout the present invention, and of the manner and process of making andusing it, in such full, clear, concise, and exact terms as to enable anyperson skilled in the art to which it pertains to make and use thisinvention. This invention is, however, susceptible to modifications andalternate constructions from that discussed above that are fullyequivalent. Consequently, this invention is not limited to theparticular embodiments disclosed. On the contrary, this invention coversall modifications and alternate constructions coming within the spiritand scope of the invention as generally expressed by the followingclaims, which particularly point out and distinctly claim the subjectmatter of the invention. While the disclosure has been illustrated anddescribed in detail in the drawings and foregoing description, suchillustration and description are to be considered illustrative orexemplary and not restrictive.

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

Unless otherwise defined, all terms (including technical and scientificterms) are to be given their ordinary and customary meaning to a personof ordinary skill in the art, and are not to be limited to a special orcustomized meaning unless expressly so defined herein. It should benoted that the use of particular terminology when describing certainfeatures or aspects of the disclosure should not be taken to imply thatthe terminology is being re-defined herein to be restricted to includeany specific characteristics of the features or aspects of thedisclosure with which that terminology is associated. Terms and phrasesused in this application, and variations thereof, especially in theappended claims, unless otherwise expressly stated, should be construedas open ended as opposed to limiting. As examples of the foregoing, theterm ‘including’ should be read to mean ‘including, without limitation,’‘including but not limited to,’ or the like; the term ‘comprising’ asused herein is synonymous with ‘including,’ ‘containing,’ or‘characterized by,’ and is inclusive or open-ended and does not excludeadditional, unrecited elements or method steps; the term ‘having’ shouldbe interpreted as ‘having at least;’ the term ‘includes’ should beinterpreted as ‘includes but is not limited to;’ the term ‘example’ isused to provide exemplary instances of the item in discussion, not anexhaustive or limiting list thereof; adjectives such as ‘known’,‘normal’, ‘standard’, and terms of similar meaning should not beconstrued as limiting the item described to a given time period or to anitem available as of a given time, but instead should be read toencompass known, normal, or standard technologies that may be availableor known now or at any time in the future; and use of terms like‘preferably,’ ‘preferred,’, ‘desired,’ or ‘desirable,’ and words ofsimilar meaning should not be understood as implying that certainfeatures are critical, essential, or even important to the structure orfunction of the invention, but instead as merely intended to highlightalternative or additional features that may or may not be utilized in aparticular embodiment of the invention. Likewise, a group of itemslinked with the conjunction ‘and’ should not be read as requiring thateach and every one of those items be present in the grouping, but rathershould be read as ‘and/or’ unless expressly stated otherwise. Similarly,a group of items linked with the conjunction ‘or’ should not be read asrequiring mutual exclusivity among that group, but rather should be readas ‘and/or’ unless expressly stated otherwise.

Where a range of values is provided, it is understood that the upper andlower limit, and each intervening value between the upper and lowerlimit of the range is encompassed within the embodiments.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity. The indefinite article ‘a’ or ‘an’ does not exclude aplurality. A single processor or other unit may fulfill the functions ofseveral items recited in the claims. The mere fact that certain measuresare recited in mutually different dependent claims does not indicatethat a combination of these measures cannot be used to advantage. Anyreference signs in the claims should not be construed as limiting thescope.

It will be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases ‘at least one’ and ‘one or more’ to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles ‘a’ or ‘an’ limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases‘one or more’ or ‘at least one’ and indefinite articles such as ‘a’ or‘an’ (e.g., ‘a’ and/or ‘an’ should typically be interpreted to mean ‘atleast one’ or ‘one or more’); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of ‘two recitations,’ without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to ‘at least one of A, B, and C, etc.’ is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., ‘a system having at least one ofA, B, and C’ would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to ‘at least one of A, B, or C, etc.’ is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., ‘a system having at leastone of A, B, or C’ would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase ‘A or B’ will be understood toinclude the possibilities of ‘A’ or ‘B’ or ‘A and B.’

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term ‘about.’ Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

Furthermore, although the foregoing has been described in some detail byway of illustrations and examples for purposes of clarity andunderstanding, it is apparent to those skilled in the art that certainchanges and modifications may be practiced. Therefore, the descriptionand examples should not be construed as limiting the scope of theinvention to the specific embodiments and examples described herein, butrather to also cover all modification and alternatives coming with thetrue scope and spirit of the invention.

What is claimed is:
 1. A system for inserting a transcutaneous analyte sensor into an individual's skin, the system comprising: an applicator housing configured to be gripped to apply the transcutaneous analyte sensor into the individual's skin; an insertion actuator coupled to the applicator housing and configured to insert a needle into the individual's skin to guide the transcutaneous analyte sensor into the individual's skin; a releasable coupler configured to retain the needle at least partially within the applicator housing; and a release actuator configured to release the needle from the releasable coupler.
 2. The system of claim 1, wherein the release actuator is configured to eject the needle from the applicator housing.
 3. The system of claim 2, wherein the release actuator includes a pressing surface configured to apply force to the needle to eject the needle from the applicator housing.
 4. The system of claim 1, wherein the release actuator includes a control device configured to be operated by the individual to cause the needle to release from the releasable coupler.
 5. The system of claim 4, wherein the control device includes a button.
 6. The system of claim 4, wherein the control device is configured to activate the insertion actuator.
 7. The system of claim 6, wherein the control device is configured to be operated in a first operation to activate the insertion actuator, and is configured to be operated in a second operation following the first operation to activate the release actuator.
 8. The system of claim 7, wherein the first operation includes pressing the control device, and the second operation includes pressing the control device.
 9. The system of claim 7, wherein the control device is configured to protrude from the applicator housing to a different distance for the first operation than for the second operation.
 10. The system of claim 1, wherein the applicator housing includes a top portion, a side portion, and a bottom portion including an opening for the transcutaneous analyte sensor to be deployed from to be inserted into the individual's skin, the release actuator configured to release the needle from the releasable coupler to allow the needle to be passed through the opening.
 11. The system of claim 1, wherein the applicator housing includes a receiver configured to receive a cartridge retaining the transcutaneous analyte sensor, and the release actuator is configured to be operated to allow the cartridge to be removed from the receiver.
 12. The system of claim 11, wherein the release actuator is configured to unlock the cartridge from the applicator housing.
 13. The system of claim 11, further comprising the cartridge, and wherein the cartridge includes a retraction actuator for retracting the needle from the individual's skin following insertion of the transcutaneous analyte sensor into the individual's skin.
 14. The system of claim 11, further comprising the cartridge, wherein the cartridge includes a bottom surface with an opening for the transcutaneous analyte sensor to be deployed from and a patch for the transcutaneous analyte sensor coupled to the bottom surface and covering the opening.
 15. The system of claim 14, wherein the cartridge is configured to allow the transcutaneous analyte sensor to slide within the cartridge relative to the patch.
 16. The system of claim 14, wherein the cartridge is configured to allow the needle to slide within the cartridge relative to the patch.
 17. The system of claim 14, wherein the patch is configured to be deployed to the individual's skin from the bottom surface of the cartridge.
 18. The system of claim 11, further comprising the cartridge, wherein the cartridge includes a keyed portion configured to align the cartridge with the receiver in a single rotational orientation.
 19. The system of claim 1, wherein the release actuator is configured to release a needle cover from the applicator housing.
 20. The system of claim 1, further comprising a cartridge retaining the transcutaneous analyte sensor, the needle, and a needle cover, and wherein the needle is configured to be moved relative to the needle cover to be positioned into the needle cover.
 21. The system of claim 20, wherein the release actuator is configured to release the needle covered by the needle cover from within the applicator housing.
 22. The system of claim 21, wherein the needle and the needle cover form a unit configured to be ejected from within the applicator housing by the release actuator. 